Apparatus for controlling flow in a bodily organ

ABSTRACT

A flow control apparatus for controlling a flow of fluid and/or other matter in a lumen formed by a tissue wall of a patient&#39;s organ. The apparatus comprises a control device adapted to control contraction of the tissue wall to influence the flow in the lumen. The apparatus further comprises an implantable constriction device adapted to gently and simultaneously constrict a series of wall portions comprising three or more wall portions of the tissue wall to influence the flow in the lumen, wherein the constriction device gently constricts the series of wall portions by constricting the series of wall portions to a constricted state in which the blood circulation in the constricted series of wall portions is substantially unrestricted and the flow in the lumen is at least restricted, and an implantable energized stimulation device adapted to individually and independently stimulate a selected wall portion of the series of wall portions, comprising three or more wall portions.

This application is a continuation of U.S. application Ser. No.12/758,684 which is a continuation-in-part of:

International Application No. PCT/SE2008/000568, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000582, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000564, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000555, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000569, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000565, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000571, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000557, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000593, filed on 2008 Oct. 13,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,918,filed on 2007 Oct. 19, and

International Application No. PCT/SE2008/000586, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,918,filed on 2007 Oct. 19, and

International Application No. PCT/SE2008/000567, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000553, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000580, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000562, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000570, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,918,filed on 2007 Oct. 19, and

International Application No. PCT/SE2008/000577, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,918,filed on 2007 Oct. 19, and

International Application No. PCT/SE2009/051130, filed 2009 Oct. 9,which claims the benefit of Swedish. Regular Application No. 0802137-0,filed on 2008 Oct. 10, and U.S. Provisional Application No. 61/227,810,filed on 2009 Jul. 23, and

International Application No. PCT/SE2008/000583, filed 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and

International Application No. PCT/SE2009/051127, filed 2009 Oct. 9,which claims the benefit of Swedish national application 0802162-8 filedon 2008 Oct. 10, and

International Application No. PCT/SE2008/000572, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and

International Application No. PCT/EP2008/008587, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,766,filed 2007 Oct. 12, and

International Application No. PCT/EP2008/008588, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,764,filed 2007 Oct. 12, and

International Application No. PCT/EP2008/008589, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,765,filed 2007 Oct. 12, and

International Application No. PCT/SE2008/000584, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,767,filed on 2007 Oct. 12, and

International Application No. PCT/EP2008/008586, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,764,filed on 2007 Oct. 12, and U.S. Provisional Application No. 60/960,765,filed on 2007 Oct. 12, and U.S. Provisional Application No. 60/960,766,filed on 2007 Oct. 12, and U.S. Provisional Application No. 60/960,767,filed on 2007 Oct. 12, and U.S. Provisional Application No. 60/960,791,filed on 2007 Oct. 15, and

International Application No. PCT/EP2008/008590, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,764,filed on 2007 Oct. 12, and U.S. Provisional Application No. 60/960,765,filed on 2007 Oct. 12, and U.S. Provisional Application No. 60/960,766,filed on 2007 Oct. 12, and U.S. Provisional Application No. 60/960,767,filed on 2007 Oct. 12, and U.S. Provisional Application No. 60/960,791,filed on 2007 Oct. 15, and

International Application No. PCT/SE2008/000573, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11, and

International Application No. PCT/SE2008/000579, filed on 2008 Oct. 10,which claims the benefit of U.S. Provisional Application No. 60/960,715,filed on 2007 Oct. 11, and U.S. Provisional Application No. 60/960,716,filed on 2007 Oct. 11 each of which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to controlling the flow of fluids and/orother bodily matter in bodily organs, and in particular, to an apparatusfor controlling the flow of fluids and/or other bodily matter in lumensformed by tissue walls of bodily organs, such as (but not limited to)the esophagus, stomach, intestines, urine bladder, urethra, ureter,renal pelvis, blood vessels, aorta, corpus cavernosum, exit veins oferectile tissue, uterine tube, vas deference and bile duct.

BACKGROUND OF THE INVENTION

There are diseases that prevent a patient from maintaining normalcontrol of the flow of fluids and/or other bodily matter in a lumen of abodily organ. (The term “patient” generally includes human beings, butmay also include animals.) For example, a patient suffering from urinaryincontinence, which is a common disease that is very embarrassing to apatient, typically occurs where the patient has lost full control ofurine flow in the urethra because of a malfunctioning of the urethralsphincter. Anal incontinence often occurs because of a malfunctioning ofthe anal sphincter, which causes an uncontrolled drainage of fecalmatter through the anus. Impotence is typically due to an inability tosufficiently reduce blood flow from the penis so that an errection canbe achieved. Reflux disease is typically due to a malfunctioning of thecardia, which causes stomach acids to be regurgitated into the esophaguswhen the stomach wall moves during digestion.

One prior solution to the problem of malfunctioning sphincters has beento implant an artificial sphincter that replaces a malfunctioningsphincter. A variety of artificial sphincters have been used in thepast. These artificial sphincters have included cuffs, clamping elementsor inflatable bands that are applied externally around the bodily organthat is connected to the malfunctioning sphincter.

For example, U.S. Pat. No. 3,750,194 discloses a hydraulic cuff appliedaround the urethra of a patient suffering from urinary incontinenceHydraulic fluid flowing to the hydraulic cuff causes the cuff to squeezethe urethra and restrict fluid flow through it.

U.S. Pat. No. 6,074,341 discloses a mechanical device in the form of aloop member that is applied around a bodily organ to replace the organ'smissing or damaged sphincter. The loop member includes a wire which isused to constrict the organ in question to close the lumen therein.

A disadvantage common to all prior artificial sphinters is that hardfibrosis may form around the artificial sphincter over time and maycause malfunction of the artificial sphincter. Thus, the formed fibrosismay sooner or later become a hard fibrotic layer which may make itdifficult for the artificial sphincter to work.

Another more serious disadvantage is that the element that constricts,clamps or restricts a bodily organ may injure the tissue wall of theorgan. Thus, a consequence of the element's constricting action on theorgan is that the element might erode into the organ over time, and in aworst case, penetrate the constricted wall portion of the organ. Inaddition, blood circulation in the constricted tissue wall portion ofthe organ is eventually hampered by the pressure exerted by the element,so that poor blood circulation, or worse, no blood circulation resultsin deterioration of the constricted tissue.

One solution to prevent tissue deterioration due to poor bloodcirculation could be to apply two or more separately operatingconstricting elements along respective tissue wall portions of the organand operate the elements sequentially, whereby each tissue wall portionwould have time to recover, i.e., restore normal blood circulation whileone of the other tissue wall portions is constricted. However, anapparatus devised in accordance with this solution would have severaldisadvantages. First, the apparatus would require a large amount ofspace, making it impractical to implant. Second, the operation of theapparatus in moving the constricting elements between constricting andnon-constricting positions day and night would require a large powersupply. Such a large power supply would necessitate the implantation ofa very large, high capacity battery and/or a sophisticated system forcontinuous wireless transmission of energy from outside the patient'sbody for frequent charging of an implanted rechargeable battery. Thus,because of its large size and high power consumption, the apparatuswould be impractical or even unrealistic. Third, a sophisticated controlsystem would be necessary to control the moving elements. Finally, sucha complicated apparatus of the type described above would significantlyadd to the costs of treating a malfunctioning sphincter.

Another solution to the problem of malfunctioning sphincters that hasbeen previously used has been the electric stimulation of the sphincter,to restore its normal function, i.e., the contraction and closing of itsassociated lumen. This solution would work where the normal sphinctericfunction is somewhat reduced and has not completely ceased. Europeanpatent application 1004330 A1 discloses an example of such a solution,in which electric pulses are delivered to the lower esophageal sphincterof a patient suffering from reflux disease to minimize reflux. However,the esophageal sphincter has to be continuously stimulated with electricpulses to keep it closed, except when the patient eats, which may resultin a decreased stimulation effect over time. An even more seriousdrawback to this solution is that the continuous stimulation over timemight cause tissue deterioration due to poor blood circulation.

The use of electric stimula to restore the sphincteric function of amalfunctioning sphincter is only possible if the sphincter respondssufficiently to the stimula, i.e., closes the lumen in question. Incases where the sphincteric function of a sphincter has completelyceased, or the sphincter has been removed from the patient's body,electric stimulation cannot be employed.

Electric stimulation of bodily organs other than sphincters can onlyinsignificantly affect the flow in the organ in question. For example,where the organ is the small intestine of an anal incontinent patient,electric stimulation of the small intestine affects fecal flow, butcould not possibly fully close the fecal passageway, at least not byemploying the necessary low stimulation intensities that are harmless tothe human body.

SUMMARY

Intestinal Dysfunction

There are diseases that prevent a patient from maintaining normalcontrol of the flow of intestinal contents in the patient's intestines,such as anal incontinence, reduced peristaltic function of theintestines and constipation intestines. (The term “patient” generallyincludes human beings, but may also include animals. Also, the term“intestines” generally includes small bowel, large bowel, and anus. Thismeans that the term “intestinal passageway” includes the entire passagefrom the stomach to the anal orifice.) In particular, anal incontinenceis a widespread disease and often occurs because of a malfunctioning ofthe anal sphincter, which causes an uncontrolled drainage of fecalmatter through the anus.

Several kinds of sphincter plastic surgery are used today to remedy analincontinence, i.e disability to close the anal sphincter. There is aprior manually operated sphincter system in an initial clinical trialphase where a hydraulic sphincter system connected to an elasticreservoir (balloon) placed in the scrotum is developed. A disadvantageof this system is that thick, hard fibrosis is created around thereservoir by pump movements making the system useless sooner or later.Another disadvantage is that the use of hydraulic fluid always entails arisk of fluid leaking from the implanted hydraulic system.

Furthermore, it is a rather complicated task to manually pump thereservoir when defecation is needed. U.S. Pat. No. 5,593,443 discloseshydraulic anal sphincter under both reflex and voluntary control. Aninflatable artificial sphincter with the pump system in scrotum isdisclosed in U.S. Pat. No. 4,222,377.

U.S. Pat. No. 4,739,764 discloses a method for treating analincontinence by electric stimulation of nerves connected to musclescontrolling the anal sphincter. The function of the anal sphincter isaffected by applying electric pulse trains on the nerves. One generalprior solution to the problem of malfunctioning sphincters of a humanbody has been to implant an artificial sphincter that replaces amalfunctioning sphincter. A variety of artificial sphincters have beenused in the past. These artificial sphincters have included cuffs,clamping elements or inflatable bands that are applied externally aroundthe bodily organ that is connected to the malfunctioning sphincter.

For example, U.S. Pat. No. 6,074,341 discloses a mechanical device inthe form of a loop member that is applied around a bodily organ toreplace the organ's missing or damaged sphincter. The loop memberincludes a wire which is used to constrict the organ in question toclose the lumen therein.

A disadvantage common to all prior artificial sphinters is that hardfibrosis may form around the artificial sphincter over time and maycause malfunction of the artificial sphincter. Thus, the formed fibrosismay sooner or later become a hard fibrotic layer which may make itdifficult for the artificial sphincter to work.

Another more serious disadvantage of the prior artificial sphincters ifused for replacing malfunctioning anal sphincters is that the element ofthe artificial sphincter that constricts, clamps or restricts theintestines may injure the tissue wall of the intestines. Thus, aconsequence of the element's constricting action on the intestines isthat the element might erode into the intestines over time, and in aworst case, penetrate the constricted wall portion of the intestines. Inaddition, blood circulation in the constricted tissue wall portion ofthe intestines is eventually hampered by the pressure exerted by theelement, so that poor blood circulation, or worse, no blood circulationresults in deterioration of the constricted tissue.

One solution to prevent tissue deterioration due to poor bloodcirculation could be to apply two or more separately operatingconstricting elements along respective tissue wall portions of theintestines and operate the elements sequentially, whereby each tissuewall portion would have time to recover, i.e., restore normal bloodcirculation while one of the other tissue wall portions is constricted.However, an apparatus devised in accordance with this solution wouldhave several disadvantages. First, the apparatus would require a largeamount of space, making it impractical to implant. Second, the operationof the apparatus in moving the constricting elements betweenconstricting and non-constricting positions day and night would requirea large power supply. Such a large power supply would necessitate theimplantation of a very large, high capacity battery and/or asophisticated system for continuous wireless transmission of energy fromoutside the patient's body for frequent charging of an implantedrechargeable battery. Thus, because of its large size and high powerconsumption, the apparatus would be impractical or even unrealistic.Third, a sophisticated control system would be necessary to control themoving elements. Finally, such a complicated apparatus of the typedescribed above would significantly add to the costs of treating amalfunctioning sphincter.

Another solution to the problem of malfunctioning sphincters that hasbeen previously used has been the electric stimulation of the sphincter,to restore its normal function, i.e., the contraction and closing of itsassociated lumen. This solution would work where the normal sphinctericfunction is somewhat reduced and has not completely ceased. Europeanpatent application 1004330 A1 discloses an example of such a solution,in which electric pulses are delivered to the lower esophageal sphincterof a patient suffering from reflux disease to minimize reflux. However,the esophageal sphincter has to be continuously stimulated with electricpulses to keep it closed, except when the patient eats, which may resultin a decreased stimulation effect over time. An even more seriousdrawback to this solution is that the continuous stimulation over timemight cause tissue deterioration due to poor blood circulation.

The use of electric stimula to restore the sphincteric function of amalfunctioning anal sphincter is only possible if the anal sphincterresponds sufficiently to the stimula, i.e., closes the intestinalpassageway of the intestines. In cases where the sphincteric function ofan anal sphincter has completely ceased, or the anal sphincter has beenremoved from the patient's body, electric stimulation cannot beemployed.

Electric stimulation of intestinal organs other than anal sphincters canonly insignificantly affect the flow of intestinal contents. Forexample, it is true that electric stimulation of the small intestine ofan anal incontinent patient affects flow of intestinal contents, butcould not possibly fully close the intestinal passageway, at least notby employing the necessary low stimulation intensities that are harmlessto the human body.

Intestinal dysfunction may also involve disability of controlling themuscle that contracts the bowels, colon or rectum to providetransportation of the content thereof. Such a disability usually causesconstipation. In particular paralysed patients may suffer fromconstipation.

Urinary Dysfunction

There are different kinds of urinary dysfunction that prevent a patientfrom maintaining normal control of the flow of urine in the patient'surethra, ureter, renal pelvis or bladder. For example, overflowincontinence, stress incontinence and urge incontinence. (The term“patient” generally includes human beings, but may also includeanimals.)

Overflow incontinence involves disability of controlling the muscle thatcontracts the urine bladder. In particular partially paralysed patientsmay suffer from this condition. Stress incontinence involves disabilityto keep the urethral sphincter completely closed. In a urinary stressincontinent patient the urethral sphincter is unable to prevent urinefrom being expelled from the bladder during transient increase inintra-abdominal pressure, which can be caused by sneezing, coughing orlaughing, or by lifting heavy goods. Urge incontinence involvesspontaneous activity of the bladder causing a compelling feeling of thepatient that the bladder needs to be emptied, although the bladder maybecontains little urine.

Urinary stress and urge incontinences are widespread diseases. Althoughsome people suffering from these diseases are helped through training ofthe muscles in the pelvic floor, too many have severe problems withurine leakage. Many different implant devices have been tried to remedythis kind of urinary incontinence. For example, there is a priormanually operated urinary incontinence treatment apparatus having anartificial hydraulic sphincter device engaging the urethra and connectedto an elastic reservoir implanted in the scrotum or in the region of thelabia majora. A disadvantage of this prior apparatus is that over timehard fibrosis is developed around the reservoir, which may causemalfunction of pumping components. Furthermore, it is a rathercomplicated task to manually squeeze the elastic implanted reservoir topump hydraulic fluid to open the sphincter device when the patient needsto urinate. In particular women can get their fingers wet. The createdfibrosis will sooner or later become a hard fibrotic layer, which maymake it even more difficult to pump the reservoir. Yet a furtherdisadvantage is that the use of hydraulic fluid always entails a risk offluid leaking from implanted hydraulic components.

A prior hydraulic apparatus designed to compress the urethra isdisclosed in U.S. Pat. No. 5,520,606. A prosthetic sphincter with aninflatable cuff, which surrounds the urethra or encloses it on twosides, is disclosed in for example U.S. Pat. Nos. 4,571,749 and4,222,377. U.S. Pat. No. 4,969,474 discloses a hydraulic method fortreating both men and women having urinary stress incontinence in thesame way. The apparatus of U.S. Pat. No. 4,969,474 includes a reservoircontaining fluid and an inflatable compression means designed tocompress the urethra without risking tissue loss or necrosis to occur.An artificial hydraulically operated urethral sphincter employing anexternal magnet to achieve closure of the urethral cuff is disclosed inU.S. Pat. No. 5,562,598.

A prior mechanical prosthetic sphincter disclosed in U.S. Pat. No.4,619,245 comprises a manually controllable actuating component forimplanting at a convenient location in the patient's body.

U.S. Pat. No. 4,739,764 discloses a method for treating urinary stressincontinence by electric stimulation of an inferior somatic nerveconnected to the urethral sphincter. The function of the urethralsphincter is affected by applying electric pulse trains on the somaticnerve.

U.S. Pat. No. 6,061,596 discloses a system for regularly conditioningand training the pelvic muscles of a urinary stress or urge incontinentpatient with electric stimulation so as to restore voluntary control tothe patient. The pelvic muscles are stimulated, i.e. conditioned, for15-60 minutes each day using intermittent trains of electrical pulses.Accordingly, during the rest of each day, i.e. at least 23 hours, thepelvic muscles are not stimulated.

U.S. Pat. Appl. Publication No. 2002/0062060 A1 discloses a urinarystress or urge incontinence treatment device, which is sensor controlledand is normally not in operation unless signals from the sensorsindicate a condition that is likely to cause involuntary urine flow. Thesensors generate signals responsive to motion or to intravesical orabdominal pressure, or to urine volume in the bladder. The signals fromthe sensors are indicative of possible incontinence that may occur dueto coughing, laughing, or other strain or motion of abdominal muscles.

One general prior solution to the problem of malfunctioning sphinctersof a human body has been to implant an artificial sphincter thatreplaces a malfunctioning sphincter. A variety of artificial sphinctershave been used in the past. These artificial sphincters have includedcuffs, clamping elements or inflatable bands that are applied externallyaround the bodily organ that is connected to the malfunctioningsphincter.

For example, U.S. Pat. No. 3,750,194 discloses a hydraulic cuff appliedaround the urethra of a patient suffering from urinary incontinence.Hydraulic fluid flowing to the hydraulic cuff causes the cuff to squeezethe urethra and restrict fluid flow through it.

U.S. Pat. No. 6,074,341 discloses a mechanical device in the form of aloop member that is applied around a bodily organ to replace the organ'smissing or damaged sphincter. The loop member includes a wire which isused to constrict the organ in question to close the lumen therein.

A disadvantage common to all prior artificial sphinters is that hardfibrosis may form around the artificial sphincter over time and maycause malfunction of the artificial sphincter. Thus, the formed fibrosismay sooner or later become a hard fibrotic layer which may make itdifficult for the artificial sphincter to work.

Another more serious disadvantage of the prior artificial sphincters ifused for replacing malfunctioning urethral sphincters is that theelement that constricts, clamps or restricts the urethra may injure thetissue wall of the urethra. Thus, a consequence of the element'sconstricting action on the urethra is that the element might erode intothe urethra over time, and in a worst case, penetrate the constrictedwall portion of the urethra. In addition, blood circulation in theconstricted tissue wall portion of the urethra is eventually hampered bythe pressure exerted by the element, so that poor blood circulation, orworse, no blood circulation results in deterioration of the constrictedtissue.

One solution to prevent tissue deterioration due to poor bloodcirculation could be to apply two or more separately operatingconstricting elements along respective tissue wall portions of theurethra and operate the elements sequentially, whereby each tissue wallportion would have time to recover, i.e., restore normal bloodcirculation while one of the other tissue wall portions is constricted.However, an apparatus devised in accordance with this solution wouldhave several disadvantages. First, the apparatus would require a largeamount of space, making it impractical to implant. Second, the operationof the apparatus in moving the constricting elements betweenconstricting and non-constricting positions day and night would requirea large power supply. Such a large power supply would necessitate theimplantation of a very large, high capacity battery and/or asophisticated system for continuous wireless transmission of energy fromoutside the patients body for frequent charging of an implantedrechargeable battery. Thus, because of its large size and high powerconsumption, the apparatus would be impractical or even unrealistic.Third, a sophisticated control system would be necessary to control themoving elements. Finally, such a complicated apparatus of the typedescribed above would significantly add to the costs of treating amalfunctioning sphincter.

Another solution to the problem of malfunctioning sphincters that hasbeen previously used has been the electric stimulation of the sphincter,to restore its normal function, i.e., the contraction and closing of itsassociated lumen. This solution would work where the normal sphinctericfunction is somewhat reduced and has not completely ceased. Europeanpatent application 1004330 A1 discloses an example of such a solution,in which electric pulses are delivered to the lower esophageal sphincterof a patient suffering from reflux disease to minimize reflux. However,the esophageal sphincter has to be continuously stimulated with electricpulses to keep it closed, except when the patient eats, which may resultin a decreased stimulation effect over time. An even more seriousdrawback to this solution is that the continuous stimulation over timemight cause tissue deterioration due to poor blood circulation.

The use of electric stimula to restore the sphincteric function of amalfunctioning urethral sphincter is only possible if the sphincterresponds sufficiently to the stimula, i.e., closes the urethra. In caseswhere the sphincteric function of a urethral sphincter has completelyceased, or the urethral sphincter has been removed from the patient'sbody, electric stimulation cannot be employed.

Electric stimulation of urinary organs other than urethral sphincterscan only insignificantly affect the flow of urine. For example, it istrue that electric stimulation of the urethra affects flow of urine, butcould not possibly fully close the relatively stiff urethra, at leastnot by employing the necessary low stimulation intensities that areharmless to the human body.

Obesity

In the past, obese patients have been treated by gastric reductionsurgery to restrict the food intake of the patient. At present, twogastric restriction procedures for treating obesity are most commonlyperformed, namely Adjustable Gastric Banding (AGB) and Vertical BandedGastroplasty (VBG).

In AGB, a constricting band is placed completely around an obesepatient's surgically intact stomach near the upper end thereof, justbelow the junction of stomach and esophagus, to restrict the food intakeof the patient. As the band constricts the stomach, a small gastricpouch, or smaller compartment of the stomach, is formed above the bandand a reduced permanent stoma in the stomach. The idea being that asmall amount of food filling the small pouch causes the patient to sensefullness, i.e., satiety. An adjustment means enables a minorpost-operation adjustment of the band and a corresponding adjustment ofthe size of the stoma opening. Typically the adjustment means includesan inflatable cavity in the band and a subcutaneously implantedinjection port in fluid connection with the inflatable cavity. Whenneeded an injection needle may penetrate the patient's skin and passinto the injection port to add fluid to the cavity to reduce the stoma,or withdraw fluid from the cavity to enlarge the stoma. Examples of AGBare disclosed in U.S. Pat. No. 4,592,339 and European Patent No.0611561,

In VBG, typically the stomach is stapled vertically with four rows oflinear staples, which compartmentalize the stomach into an elongateproximal smaller compartment adjacent the esophagus and a distal largercompartment, so that the volume of the smaller compartment is about 10%of the volume of the stomach. A circular hole is punched-out in thestomach at the lower end of the rows of linear staples and severalcircular rows of staples are placed on the stomach around the circularhole. A band is placed through the circular hole and is secured aroundthe stomach, whereby the band defines a narrow outlet opening from thesmaller compartment into the larger compartment of the stomach. Oncesecured, the band prevents the stomach from stretching at the outletopening, which results in that the outlet opening over time maintainsits initial small diameter. Food that the patient takes in is held up inthe smaller compartment causing the sensation of fullness. Then, thefood empties slowly through the outlet opening into the largercompartment where digestion takes place normally. Examples of VBG aredisclosed in U.S. Pat. Nos. 5,345,949 and 5,549,621.

The operation described above called “VBG” encompasses a group ofoperation variants. Thus, the staples may be replaced by stitches or anyother suitable means that secure the front and back walls of the stomachtogether, such as clamping bars. The stomach may be cut between the fourrows of linear staples, which eliminates the need for punching out acircular hole for the band, because the band can be placed through thecut at the lower end of the of the staple rows. Also, the cut betweenthe four rows of linear staples may expand into a small hole forreceiving the band at the lower end of the of the staple rows.Alternatively, the band may not be placed through any cut or punched-outhole in the stomach, but may be attached to the front and back walls ofthe stomach by means of stitches or the like.

There are few complications associated with VBG. However, it isimportant that the patient very carefully chews food completely beforeswallowing it, so that food pieces collected in the smaller compartmentof the stomach are able to pass through the narrow outlet opening of thesmaller compartment. If food pieces were stuck in the outlet opening itmight cause the patient to vomit and feel sick. In such a case thepatient should have to visit a doctor or nurse. Another complicationassociated with VBG is that the patient may suffer from add stomachreflux at night. These complications are also experienced with AGB.

Sexual Dysfunction

Male sexual impotence is a widespread problem. Many different solutionsto this problem have been tried. A main solution currently practised anddisclosed in for instance U.S. Pat. Nos. 5,437,605 and 4,841,461 is toimplant a hydraulic inflatable/contractible silicon prosthesis in thecavities of the corpora cavernosa of the patient's penis. In fluidconnection with this prosthesis is a reservoir implanted in the scrotum.By manual pumping action the prosthesis is filled with fluid from thereservoir to effect errect condition or is emptied of fluid, whichreturns to the reservoir, to effect flaccid condition.

However, there are several more or less severe disadvantages of thismain solution. Above all, the penis is more or less damaged by theoperation and it is practically impossible to reverse the operation.Another disadvantage is that rather strong forces act against thisimplanted prosthesis resulting in a significant risk of the prosthesisbeing broken. A further disadvantage is that hard fibrosis createdaround the reservoir over time may cause malfunction of pumpingcomponents. Thus, the created fibrosis will sooner or later become ahard fibrotic layer which may make it difficult to pump the reservoir.Yet a further disadvantage is that the use of hydraulic fluid alwaysentails a risk of fluid leaking from the prosthesis. Furthermore, it isa rather complicated task to manually pump the reservoir when erectionis desired.

Another solution is to inject a substance in the vein system to achieveerection. However, injections are painful and complicated for thepatient.

Yet another solution to achieve erection is to restrict the blood flowleaving the penis. For example, U.S. Pat. No. 4,829,990 discloses twohydraulically operated inflatable cuffs wrapped around the respectivecrura. Again, a disadvantage of such a solution is that it entails arisk of hydraulic fluid leaking from the cuffs.

Another example of the solution to restrict the penile blood flow isfound in U.S. Pat. No. 4,828,544, which discloses an artificial fistulasystem surgically implanted and providing a primary fistula between thefemoral artery and the femoral vein and a secondary fistula for leadingblood from the primary fistula to the penis. An inflatable balloonengages the primary fistula between the secondary fistula and the vein.The balloon is in fluid connection with a manually compressiblereservoir implanted in the scrotum. Besides the risk of fluid leakingfrom the balloon, a further disadvantage of this latter example is thatit requires delicate surgery.

Yet another example of the solution to restrict the penile blood flow isfound in EP 1253877 B1, which discloses an adjustable restriction devicethat directly clamps a portion of the normal penile tissue or theprolongation thereof of the patient. There is an adjustment device thatmechanically adjusts the restriction device to temporarily contract theportion of the normal penile tissue or the prolongation thereof torestrict the blood flow leaving the penis, when the patient desires toachieve erection.

A serious disadvantage of the prior art devices that constrict clamp thepatient's penile tissue to restrict the exit penile blood flow is thatthe element that constricts, clamps or restricts the penile portion mayinjure the tissue wall of the penile portion. Thus, a consequence of theelement's constricting action on the penile portion is that the elementmight erode into the penile portion over time, and in a worst case,penetrate the constricted penile portion of the penile portion.

A lot of attention has been given to male sexual disorders includingimpotence. This has lead to the availability of a number of treatmentoptions for males, including pharmaceuticals such as Viagra.

In contrast, there is a lack of therapies for treating Female SexualDysfunction (FSD). Female sexual dysfunction such as disorders of sexualdesire, arousal or orgasm is a common problem, affecting up to 43% ofall women (Pauls et al, Obstret Gynecol Surv, 2005 60(3):3196-205). Bothbiological and psychological factors contribute to FSD.

Available treatments include psychological counselling to pairs orindividuals. Where side effects of medication contribute to FSD,altering medication or dosage may help. However, there is a need forimproved treatment of FSD.

During sexual arousal of the female, vasocongestion of the pelvic regionleads to engorgement of the genitalia with blood leading to swelling ofthe external genitalia and erection of the clitoris. This is accompaniedby lubrication of the vagina. In the female, the corpus cavernosa aretwo paired symmetrical extensions of the clitoris and engorgement ofthese is an important step during sexual arousal of the female.

Female sexual arousal is enhanced by stimulation of the vulva, bytouching or caressing the clitoris, which for example contributes toarousal.

Hand held or other external devices that stimulate the clitoris arewell-known. For example U.S. Pat. No. 7,081,087B2 discloses a sexual aidthat vibrates. There has been proposed a device for treating FSD thatapplies a vacuum or suction to the clitoris. This will create a negativepressure that promotes the engorgement of the clitoris with blood(Hovland Claire, U.S. Pat. No. 6,464,653B1).

The local administration of prostaglandins to the female genitalia inorder to treat FSD has been described in U.S. Pat. No. 6,486,207. Theimplantation of an electrode that stimulates the peripheral nerves ofthe vulva has been described (US 2008/0103544).

In spite of the available treatments for female sexual dysfunction thereis still a need for improved treatment of female sexual dysfunction.

Pregnancy Control

Many women have difficulties getting pregnant. Old age when trying toget pregnant with lower fertility rate is one main reason. Artificialinsemination is one way of promoting pregnancy that has increaseddramatically in recent years. However, this method is not always easyand safe and is furthermore very expensive, particularly when repeated,which often is the case. Although uterus is prepared to accomodate anembryo for as long as approximately three days it seems that the righttiming is of outmost importance when fertility goes down. Conceptivedrugs may cause blood clots and other serious complications.

On the other hand pregnancy may be undesired. In this case, a women maychoose among a variety of known birth control devices, for examplecontraceptive or antifertility agents, or pessaries.

Blood Flow Control

There are diseases that prevent a patient from maintaining normalcontrol of the flow of blood in the vascular system. One example is apatient suffering from high blood pressure in the lungs. This state mayif untreated cause gradual degradation of the normal lung function.Another example is a patient with an abnormal distribution of the bloodflow. Treating high bloodpressure locally or redistributing blood may beuseful in many applications.

A disadvantage common to all prior artificial moving implants is thathard fibrosis may form around the artificial moving implant over timeand may cause malfunction of the artificial moving implant. Thus, theformed fibrosis may sooner or later become a hard fibrotic layer whichmay make it difficult for the artificial moving implant to work.

Another more serious disadvantage is that elements of the artificialmoving implants that constricts, clamps or constricts a blood vessel mayinjure the wall of the blood vessel. Thus, a consequence of theelement's constricting action on the blood vessel is that the elementmight erode into the blood vessel over time, and in a worst case,penetrate the constricted wall portion of the blood vessel.

One solution to prevent harmful effects from the pressure of theartificial implant is to apply two or more separately operatingconstricting elements along the blood vessel and operate the elementssequentially on respective wall portions of the blood vessel, wherebyeach blood vessel portion would have time to recover, while one of theother part of the blood vessel is constricted. However, an apparatusdevised in accordance with this solution would have severaldisadvantages. First, the apparatus would require a large amount ofspace, making it impractical to implant. Second, the operation of theapparatus in moving the constricting elements between constricting andnon-constricting positions day and night would require a large powersupply. Such a large power supply would necessitate the implantation ofa very large, high capacity battery and/or a sophisticated system forwireless transmission of energy from outside the patient's body forfrequent charging of an implanted rechargeable battery. Thus, because ofits large size and high power consumption, the apparatus would beimpractical or even unrealistic. Third, a sophisticated control systemwould be necessary to control the moving elements. Finally, such acomplicated apparatus of the type described above would significantlyadd to the costs of treatment by an artificial implant.

Vascular Aneurysm

An aneurysm (or aneurism) is a localized, blood-filled dilation(balloon-like bulge) of a blood vessel caused by disease or weakening ofthe vessel wall. Aneurysms most commonly occur in arteries at the baseof the brain (the circle of Willis) and in the aorta (the main arterycoming out of the heart), a so-called aortic aneurysm. The bulge in ablood vessel can burst and lead to severe internal hemorragh and deathat any time. The larger an aneurysm becomes, the more likely it is toburst and since aneurysms naturally grow, given enough time they willinevitably reach the bursting point if undetected.

Given the severe consequences of an aneurysm, screening is now commonlyperformed in order to early detect the presence of an aneurysm. In caseof an aortic aneurysm the blood-filled dilation is commonly located inthe abdomen close to the Y-bifurcation extending to the legs. At thislocation the aorta is typically about 2.5 centimeters wide, which can bemeasured for example using ultra-sonic or X-ray based measuring devices.

Existing treatment when detecting an aortic aneurysm includesimplantation of a stent around the vessel using open surgery. Analternative surgical procedure is to implant a tube from the groin andguide the stent via arteria femoralis into position where the blood flowcan by-pass the aortic aneurysm via the tube. The latter treatment hasthe drawback that an embolism is easily formed when alien material isintroduced into the bloodstream.

Hence, there exists a need for a treatment of aortic aneurysm that ismore robust and which brings about fewer complications.

Male Contraception

A common route of male contraception is occlusion of vas deference (thesperm transporting duct). Vasectomy is a surgical intervention to cutvas deference and is most frequently a confinement to permanentsterility. More recently, other alternatives have become available bythe provision of devices to be inserted into vas deference and obtain asealing effect. One such technique is described in U.S. Pat. No.6,513,528 that relates to a set of silicone plugs for insertion into vasdeference. However, even if this technology represents a possibility toreverse the individual to fertility, it is also associated with sideeffects, such as sperm antibody formation. It is therefore a need for amore gentle technique to obtain controlled male contraception whichadmits reversibility with minimal affection of body functions.

Gallstones

Cholelithiasis (gallstones) is the presence or formation of gallstonesin the biliary tract. It can cause intense pain and is potentiallydangerous. It is a common medical problem, affecting 10 to 15 percent ofthe population.

Bile is formed in the gallbladder and consists of water, cholesterol,fats, bile salts, proteins, and bilirubin. The main function is tosecrete bile salts that emulsify dietary fats and to secrete bilirubin,which is a waste product. Bile is produced by hepatocytes of the liverand transported to the gall bladder were it is stored for release intothe duodenum. Bile is transported through a system of ducts. The ductsinclude the hepatic ducts, which carry bile out of the liver, the cysticduct, which takes bile to and from the gallbladder, and the common bileduct, which takes bile from the cystic and hepatic ducts to the smallintestine. These three ducts together with the sphincters that controlthem are referred to herein as the “biliary duct” or the “biliaryducts”. Biliary ducts has smooth muscle tissue, that enables the ductsto contract.

Gallstones may form when cholesterol or bilirubin precipitates into hardaggregates. Gallstones can block the normal flow of bile if they movefrom the gallbladder and lodge in any of the ducts that carry bile fromthe liver to the small intestine Symptoms of blocked bile ducts includeintense pain and are often referred to as a gallbladder “attack” becausethey occur suddenly. If any of the biliary ducts remain blocked bygallstones for a significant period of time, severe damage or infectioncan occur in the gallbladder, liver, or pancreas. Left untreated, thecondition can be fatal.

The most common treatment for gallstones is the complete removal of thegallbladder (cholecystectomy). Present data suggest that the gallbladderis a nonessential organ and that patient can live a normal life withoutthe gallbladder, as bile can instead reach the intestines via directflow from the liver through the hepatic ducts into the common bile ductand into the small intestine, instead of being stored in thegallbladder.

Removal of the call bladder is usually performed using laparascopicalprocedures. However, open surgery is necessary in about 5 percent ofgallbladder operations. Recovery from open surgery usually requires 3 to5 days in the hospital and several weeks at home.

A serious disadvantage with the current treatment is the riskt forserious damage to the bile duct during surgery. This is a seriousproblem and requries additional surgery.

Another disadvantage is that a high percentage of patients suffer fromdiahorrea permanently or for a long time after removal of the gallbladder.

Intestinal Disorders

In an attempt to overcome intestinal disorders, many different solutionshave been proposed. These solutions often include surgery, in particularwhere a portion of the intestine has to be removed. The reason for suchoperation may be colorectal cancer, perforated diverticulitis or otherkinds of diseases, such as ulceros colitis or Crohns disease. Forinstance, in the case of ileostomy, jejunostomy, colostomy andrectostomy operations the small intestine (jejunum or ileum) or thelarge Intestine (colon or rectum) is cut and the open end of the healthyportion of the intestine is reattached either to a surgically createdstoma in the patient's abdominal wall or, where possible, to thepatient's rectum or anus or to tissue adjacent the patient's anus.

The problem then arises to control the intestinal contents flow and,more particularly, to prevent feces from exiting the patient's bodyuncontrolled. The patient is typically required to excrete into acolostomy bag. This is obviously inconvenient and, in addition, maycause skin irritation since such a bag arrangement requires an adhesiveplate to be attached to the patient's skin in order to render the bagliquid tight.

U.S. Pat. No. 4,222,377 suggests the use of an inflatable artificialsphincter comprising a cuff around the anal or urethral canal. Amanually operated pump is implanted in the patient's scrotum forinflating and deflating the artificial sphincter.

Similarly, U.S. Pat. No. 5,593,443 discloses an artificial hydraulicanal sphincter under voluntary control. More specifically, the patientmay actuate a mechanical or electrical pump for inflating and deflatinga cuff. The cuff consists of two parts positioned on opposite sides ofthe intestine and pressing the intestinal walls together when inflated.

U.S. Pat. No. 6,752,754 B1 discloses an artificial rectum for replacinga portion of a patient's rectum. An inlet of the artificial rectum isoperatively connected to the distal end of the patient's large intestineand communicates fecal matter to a macerator-type pump that dischargesthe feces through an outlet of the artificial rectum connected to thepatient's anus. The pump includes a helical screw-type impeller, whichwhen rotated creates shearing effects on the feces, causing it to movedown the thread of the screw impeller and discharge through thepatient's anus.

BRIEF SUMMARY OF THE INVENTION

The object of the present invention is to provide an apparatus forcontrolling the flow of fluids and/or other bodily matter in lumensformed by tissue walls of bodily organs, so as to at least substantiallyor even completely eliminate the injured tissue wall problems that haveresulted from implanted prior art devices that constrict such bodilyorgans. The term “bodily organ” includes (but not limited to) theesophagus, stomach, intestines, urine bladder, urethra, ureter, renalpelvis blood vessels, aorta, corpus cavernosum, exit veins of erectiletissue, uterine tube, vas deference and bile duct.

In accordance with this object of the present invention, there isprovided an apparatus for controlling the flow of fluids and/or otherbodily matter in a lumen that is formed by the tissue wall of a bodilyorgan, the apparatus comprising an implantable constriction device forgently constricting a portion of the tissue wall to influence the flowin the lumen, a stimulation device for stimulating the wall portion ofthe tissue wall, and a control device for controlling the stimulationdevice to stimulate the wall portion as the constriction deviceconstricts the wall portion to cause contraction of the wall portion tofurther influence the flow in the lumen.

The present invention provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stageinfluence on the flow of fluids and/or other bodily matter in the lumenof a bodily organ. Thus, the constriction device may gently constrictthe tissue wall by applying a relatively weak force against the wallportion, and the stimulation device may stimulate the constricted wallportion to achieve the desired final influence on the flow in the lumen.The phrase “gently constricting a portion of the tissue wall” is to beunderstood as constricting the wall portion without substantiallyhampering the blood circulation in the tissue wall.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the organ allows tissue of the wall portion to maintainsubstantially normal blood circulation during the operation of theapparatus of the invention.

The combination of the constriction and stimulation devices enablesapplication of the apparatus of the invention at any place on any kindof bodily organs, in particular, but not limited to, tubular bodilyorgans, which is a significant advance in the art, as compared withprior stimulation devices that are confined to electric stimulation ofmalfunctioning sphincters.

In most applications using the present invention, there will be dailyadjustments of the implanted constriction device. Therefore, in apreferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionas desired, wherein the control device controls the constriction deviceto adjust the constriction of the wall portion. The control device maycontrol the constriction and stimulation devices independently of eachother, and simultaneously. Optionally, the control device may controlthe stimulation device to stimulate, or to not stimulate the wallportion while the control device controls the constriction device tochange the constriction of the wall portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow in the lumen is obtained.

Flow Restriction

The apparatus of the present invention is well suited for restrictingthe flow of fluids and/or other bodily matter in the lumen of a bodilyorgan. Thus, in a principal embodiment of the invention, theconstriction device is adapted to constrict the wall portion to at leastrestrict the flow in the lumen, and the control device controls thestimulation device to cause contraction of the constricted wall portion,so that the flow in the lumen is at least further restricted.Specifically, the constriction device is adapted to constrict the wallportion to a constricted state in which the blood circulation in theconstricted wall portion is substantially unrestricted and the flow inthe lumen is at least restricted, and the control device controls thestimulation device to cause contraction of the wall portion, so that theflow in the lumen is at least further restricted when the wall portionis kept by the constriction device in the constricted state.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the wall portion, such that flow in the lumen is restrictedbut not stopped, and controls the stimulation device to stimulate theconstricted wall portion to cause contraction thereof, such that flow inthe lumen is further restricted but not stopped. More precisely, thecontrol device may control the stimulation device in a first mode tostimulate the constricted wall portion to further restrict but not stopthe flow in the lumen and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to increase the flow in the        lumen; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the flow in the lumen.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat flow in the lumen is restricted but not stopped, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that flow in the lumen is stopped. Moreprecisely, the control device may control the stimulation device in afirst mode to stimulate the constricted wall portion to further restrictbut not stop the flow in the lumen and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to allow flow in the lumen; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the flow in the lumen.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the lumen is substantially stopped, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that the flow in the lumen is completelystopped. More precisely, the control device may control the stimulationdevice in a first mode to stimulate the constricted wall portion tocompletely stop the flow in the lumen and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to allow flow in the lumen; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the flow in the lumen.

For example, the third flow restriction option may be applied where thepresent invention is used for controlling fecal flow of an analincontinent patient. Thus, the restriction and stimulation devices maybe implanted on any part of the incontinent patient's large or smallintestines to serve as an artificial anal sphincter. Betweendefecations, the control device controls the constriction device togently flatten a portion of the intestines to at least almost completelystop the fecal flow in the intestines, and controls the stimulationdevice to stimulate the flattened portion to insure that the fecal flowis completely stopped. Since the control device controls the stimulationdevice to intermittently and individually stimulate the areas of thewall portion, as stated above in paragraph 0015, the risk of theimplanted constriction device injuring the intestines over time issignificantly reduced or even eliminated, and it is insured that theeffect of the stimulation is maintained over time. When the patientwants to defecate, the control device controls the constriction andstimulation devices to release the portion of the intestines and ceasethe stimulation, whereby fecal matter may pass the portion of theintestines. However, it should be noted that in some other applicationsof the present invention, for example where the invention is used forcontrolling urine flow of a urinary incontinent patient, it may sufficeto just cease the stimulation to achieve fluid flow through the organ inquestion.

Where the stimulation device stimulates the constricted wall portion tocontract, such that the flow in the lumen is stopped, the control devicesuitably controls the stimulation device to simultaneously andcyclically stimulate a first length of the constricted wall portion anda second length of the constricted wall portion, which is locateddownstream of the first length, wherein the control device controls thestimulation device to progressively stimulate the first length in theupstream direction of the lumen and to progressively stimulate thesecond length in the downstream direction of the lumen.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the lumen, such that the flowin the lumen remains stopped. Any sensor for sensing a physicalparameter of the patient, such as a pressure in the patients body thatrelates to the pressure in the lumen may be provided, wherein thecontrol device controls the stimulation device in response to signalsfrom the sensor. Such a sensor may for example sense the pressure in thepatient's abdomen, the pressure against the implanted constrictiondevice or the pressure on the tissue wall of the bodily organ.

For example, a pressure sensor may be applied where the presentinvention is used for controlling urine flow of a urinary incontinentpatient. Thus, the constriction and stimulation devices may be appliedon the urinary incontinent patient's urethra or urine bladder to serveas an artificial sphincter, wherein the constriction device constrictsthe urethra or urine bladder, such that the urine flow is substantiallystopped, and the stimulation device stimulates the constricted urethraor urine bladder to cause contraction thereof to completely stop theurine flow. The control device controls the stimulation device toincrease the stimulation intensity in response to signals from thepressure sensor sensing a sudden increase in the pressure in thepatient's bladder or abdominal cavity, whereby the urine flow remainsstopped and the patient maintains continence. In this manner, thepresent invention insures that the patient even is continent when he orshe sneezes or coughs, or performs other physical activity that causes asudden pressure increase in the patient's bladder/urinary tract.

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the lumen is stopped. More precisely, the controldevice may control the constriction device in a first mode to constrictthe constricted wall portion to stop the flow in the lumen and in asecond mode to cease the constriction of the wall portion to restoreflow in the lumen. In this case, the control device only controls thestimulation device to stimulate the wall portion when needed. A sensorfor sensing a physical parameter of the patient's body that relates tothe pressure in the lumen may be provided, wherein the control devicecontrols the stimulation device in response to signals from the sensor.Such a physical parameter may be a pressure in the patient's abdomen andthe sensor may be a pressure sensor.

For example, the fourth flow restriction option may be applied where thepresent invention is used for controlling urine flow of a urinaryincontinent patient in a manner similar to the situation described inthe foregoing paragraph 0026. However, in this example stimulation isonly applied when necessary to maintain continence, Thus, the controldevice controls the stimulation device to stimulate the urethra or urinebladder to cause contraction thereof in response to signals from thepressure sensor sensing a sudden increase in the pressure in thepatient's bladder or abdominal cavity, when the patient sneezes orcoughs, or performs other physical activity. As a result, the urine flowremains stopped and the patient maintains continence.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the patient's wall portion of the organin the constricted state. In this case, the control device may be usedwhen needed, conveniently by the patient, to control the stimulationdevice to stimulate the constricted tissue wall portion, preferablywhile adjusting the stimulation intensity, to cause contraction of thewall portion, such that the flow in the lumen is at least furtherrestricted or stopped, and to control the stimulation device to ceasethe stimulation. More precisely, the control device may:

-   -   a) control the stimulation device in a first mode to stimulate        the constricted wall portion to further restrict the flow in the        lumen, and control the stimulation device in a second mode to        cease the stimulation of the wall portion to increase the flow        in the lumen; or    -   b) control the stimulation device in a first mode to stimulate        the constricted wall portion to stop the flow in the lumen, and        control the stimulation device in a second mode to cease the        stimulation of the wall portion to allow flow in the lumen.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions of the organ's tissue wall, respectively. The control devicemay control the constriction device to activate the constrictionelements in random or in accordance with a predetermined sequence. Inthis case, the stimulation device includes stimulation elementspositioned on the constriction elements, wherein the control devicecontrols the stimulation device to activate the stimulation elements tostimulate any wall portions of the series of wall portions constrictedby said constriction elements to contract the organ to close the organ'slumen.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence toclose the organ's lumen. The design of the constriction device in theform of a plurality of separate constriction elements makes possible tocounteract growth of hard fibrosis where the constriction device isimplanted.

Movement of Fluid and/or Other Bodily Matter in Lumen

The apparatus of the invention can be used for actively moving the fluidand/or other bodily matter in the lumen of a patient's organ, asdescribed in the embodiments of the invention listed below.

1) The control device controls the constriction device to close thelumen, either at an upstream end or a downstream end of the wallportion, and then controls the constriction device to constrict theremaining part of the wall portion to move the fluid and/or other bodilymatter in the lumen.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the flowin the lumen. The control device controls the stimulation device tostimulate the wall portion constricted by the constriction device toclose the lumen, either at an upstream end or a downstream end of thewall portion, and simultaneously controls the constriction device toincrease the constriction of the wall portion to move the fluid and/orother bodily matter in the lumen.

2) The constriction device is adapted to constrict the wall portion torestrict or vary the flow in the lumen, and the control device controlsthe stimulation device to progressively stimulate the constricted wallportion, in the downstream or upstream direction of the lumen, to causeprogressive contraction of the wall portion to move the fluid and/orother bodily matter in the lumen.

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion, such that thewall portion is progressively constricted in the downstream or upstreamdirection of the lumen to move the fluid and/or other bodily matter inthe lumen. The constriction device may include at least one elongatedconstriction element that extends along the wall portion, wherein thecontrol device controls the elongated constriction element toprogressively constrict the wall portion in the downstream or upstreamdirection of the lumen.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the lumen. Suitably, the elongatedconstriction element comprises contact surfaces dimensioned to contact alength of the wall portion, when the constriction device constricts thewall portion, and the stimulation device comprises a plurality ofstimulation elements distributed along the contact surfaces, such thatthe stimulation elements stimulate the different areas of the wallportion along the length of the wall portion, when the control devicecontrols the stimulation device to stimulate the wall portion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to at least restrict the flow in thelumen. The control device controls the constriction device tosuccessively constrict the wall portions of the series of wall portionsto move the fluid and/or other bodily matter in the lumen in aperistaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the tissue wall, respectively.The control device controls the constriction device to activate theconstriction elements one after the other, so that the wall portions ofthe series of wall portions are successively constricted along theorgan, whereby the fluid and/or other bodily matter in the lumen ismoved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the organ to successively constrict the wallportions of the series of wall portions, wherein the control devicecontrols the constriction device to cyclically move the constrictionelement along the wall portions of the series of wall portions.Preferably, the constriction device comprises a plurality ofconstriction elements, each of which is moveable along the wall of theorgan to successively constrict the wall portions of the series of wallportions, wherein the control device controls the constriction device tocyclically move the constriction elements one after the other along thewall portions of the series of wall portions. Specifically, theconstriction device includes a rotor carrying the constriction elements,and the control device controls the rotor to rotate, such that eachconstriction element cyclically constricts the wall portions of theseries of wall portions. Each constriction element suitably comprises aroller for rolling on the wall of the organ to constrict the latter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the lumen. Where the constriction device includes atleast one constriction element, the stimulation device suitably includesat least one stimulation element positioned on the constriction elementfor stimulating the wall portion constricted by the constriction elementto close the lumen.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the lumen.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to restrict the flow in the lumen,wherein the constriction device includes a plurality of constrictionelements adapted to constrict the wall portions of the tissue wall,respectively, and the stimulation device includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the lumen.The control device controls the constriction device to activate theconstriction elements to constrict the wall portions of the series ofwall portions without completely closing the organ's lumen, and controlsthe stimulation device to activate the stimulation elements to stimulatethe wall portions one after the other, so that the wall portions of theseries of wall portions are successively contracted along the organ tomove the fluid and/or other bodily matter in the lumen of the patient'sorgan.

6) The constriction device comprises a first constriction element forconstricting the wall portion at an upstream end thereof, a secondconstriction element for constricting the wall portion at a downstreamend thereof, and a third constriction element for constricting the wallportion between the upstream and downstream ends thereof. The controldevice controls the first, second and third constriction elements toconstrict and release the wall portion independently of one another.More specifically, the control device controls the first or secondconstriction element to constrict the wall portion at the upstream ordownstream end thereof to close the lumen, and controls the thirdconstriction element to constrict the wall portion between the upstreamand downstream ends thereof, whereby the fluid and/or other bodilymatter contained in the wall portion between the upstream and downstreamends thereof is moved downstream or upstream in the lumen. Optionally,the control device controls the stimulation device to stimulate the wallportion between the upstream and downstream ends thereof, when the thirdconstriction element constricts the wall portion.

6a) In accordance with a first alternative, the control device controlsthe first constriction element to constrict the wall portion at theupstream end thereof to restrict the flow in the lumen and controls thestimulation device to stimulate the constricted wall portion at theupstream end to close the lumen. With the lumen closed at the upstreamend of the constricted wall portion, the control device controls thethird constriction element to constrict the wall portion between theupstream and downstream ends thereof, and optionally controls thestimulation device to simultaneously stimulate the wall portion as thelatter is constricted by the third constriction element. As a result,the fluid and/or other bodily matter contained in the wall portionbetween the upstream and downstream ends thereof is moved downstream inthe lumen.

6b) In accordance with a second alternative, the control device controlsthe second constriction element to constrict the wall portion at thedownstream end thereof to restrict the flow in the lumen and controlsthe stimulation device to stimulate the constricted wall portion at thedownstream end to close the lumen. With the lumen closed at thedownstream end of the constricted wall portion, the control devicecontrols the third constriction element to constrict the wall portionbetween the upstream and downstream ends thereof, and optionallycontrols the stimulation device to simultaneously stimulate the wallportion as the latter is constricted by the third constriction element.As a result, the fluid and/or other bodily matter contained in the wallportion between the upstream and downstream ends thereof is movedupstream in the lumen.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion with electric pulses.

Where the organ is tubular in shape, such as the small intestines, aparticularly long wall portion of the tubular organ may be surgicallyprepared to extend in zigzag with adjacent walls stitched together bytwo parallel rows of stitches and with the adjacent walls cut throughbetween the two rows of stitches. As a result, the lumen of this longwall portion of the organ can be significantly expanded. In this case,the constriction device of the apparatus of the invention is able tomove a considerably larger volume of fluid each time it constricts thelong wall portion of the organ.

The various solutions described above under the headline: “Flowrestriction” to stop the flow in the lumen of the organ may also be usedin any of the above noted embodiments (1a), (1b), (4a), (5), (6), (6a)and (6b).

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of theorgan, such that at least two of the areas are stimulated at differentpoints of time that is, the stimulation is shifted from one area toanother area over time. In addition, the control device controls thestimulation device, such that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before the stimulation device stimulates the areaagain. Furthermore, the control device controls the stimulation deviceto stimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the organ to achieve the desired flow control, whileessentially maintaining over time the natural physical properties of theorgan without risking injuring the organ.

Also, by physically changing the places of stimulation on the organ overtime as described above it is possible to create an advantageouschanging stimulation pattern on the organ, in order to achieve a desiredflow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall during the stimulation thereof, the controldevice may control the stimulation device to, preferably cyclically,vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with said second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue wall portion of the patient's bodilyorgan, preferably with electric pulses. This embodiment is particularlysuited for applications in which the wall portion includes muscle fibersthat react to electrical stimula. In this embodiment, the control devicecontrols the stimulation device to stimulate the wall portion withelectric pulses preferably in the form of electric pulse trains, whenthe wall portion is in the constricted state, to cause contraction ofthe wall portion. Of course, the configuration of the electric pulsetrains may be similar to the above described pulse trains and thecontrol device may control the stimulation device to electricallystimulate the different areas of the wall of the organ in the samemanner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the organ, such that the elongate pattern ofelectrical elements extends lengthwise along the wall of the organ, andthe elements abut the respective areas of the wall portion. The elongatepattern of electrical elements may include one or more rows ofelectrical elements extending lengthwise along the wall of the organ.Each row of electrical elements may form a straight, helical or zig-zagpath of electrical elements, or any form of path. The control device maycontrol the stimulation device to successively energize the electricalelements longitudinally along the elongate pattern of electricalelements in a direction opposite to, or in the same direction as thatof, the flow in the patient's lumen.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the lumen ofthe organ is to be kept closed for a relatively long time, the controldevice may control the stimulation device to energize the electricalelements, such that energized electrical elements form two waves ofenergized electrical elements that simultaneously advance from thecenter of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements. Suchwaves of energized electrical elements can be repeated over and overagain without harming the organ and without moving fluid or gas in anydirection in the lumen of the organ.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's organ. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's organ, preferably substantially transverse to theflow direction in the lumen of the organ. In a third alternative, theelements of the group of energized electrical elements may form morethan two paths of energized electrical elements extending on differentsides of the patient's organ, preferably substantially transverse to theflow direction in the patient's lumen.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's organ inthe flow direction in the patient's lumen. The electrical elements ofeach group of electrical elements may form a path of elements extendingat least in part around the patient's organ. In a first alternative, theelectrical elements of each group of electrical elements may form morethan two paths of elements extending on different sides of the patient'sorgan, preferably substantially transverse to the flow direction in thepatient's lumen. The control device may control the stimulation deviceto energize the groups of electrical elements in the series of groups inrandom, or in accordance with a predetermined pattern. Alternatively,the control device may control the stimulation device to successivelyenergize the groups of electrical elements in the series of groups in adirection opposite to, or in the same direction as that of, the flow inthe patient's lumen, or in both said directions starting from a positionsubstantially at the center of the constricted wall portion. Forexample, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's organ such that theelongate pattern of electrical elements extends along the organ in thesame direction as that of the flow in the patient's lumen and theelements abut the respective areas of the wall portion of the organ.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the organ. Thus, the control device maycontrol the stimulation device to cool the wall portion, when the wallportion is constricted, to cause contraction of the wall portion. Forexample, the constriction device may constrict the wall portion to atleast restrict the flow in the lumen, and the control device may controlthe stimulation device to cool the constricted wall portion to causecontraction thereof, such that the flow in the lumen is at least furtherrestricted, or further restricted but not stopped, or stopped.Alternatively, the control device may control the stimulation device toheat the wall portion, when the wall portion is constricted andcontracted, to cause expansion of the wall portion. Where the wallportion includes a blood vessel, the control device may control thestimulation device to cool the blood vessel to cause contractionthereof, or heat the blood vessel to cause expansion thereof. Whereapplicable, thermal stimulation may be practised in any of theembodiments of the present invention, and the thermal stimulation may becontrolled in response to various sensors, for example strain, motion orpressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing organ motion, i.e. naturalcontractions, such as stomach or intestinal contractions, pressuresensors for sensing pressure in the organ, strain sensors for sensingstrain of the organ, flow sensors for sensing fluid flow in the lumen ofthe organ, spectro-photometrical sensors, Ph-sensors for sensing acidityor alkalinity of the fluid in the lumen of the organ, oxygen-sensorssensors for sensing the oxygen content of the fluid in the lumen of theorgan, or sensors for sensing the distribution of the stimulation on thestimulated organ. Any conceivable sensors for sensing any other kind ofuseful physical parameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the lumen of the patient's bodily organ, wherein the control devicecontrols the constriction device and/or stimulation device to change theconstriction of the patient's wall portion in response to the pressuresensor sensing a predetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patients wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's wall portion to increase or decrease the influence on the flowin the lumen during different time periods of the day. In case a sensorof any of the above-described types for sensing a physical or functionalparameter is provided, either the clock mechanism is used forcontrolling the constriction device and/or stimulation device providedthat the parameter sensed by the sensor does not override the clockmechanism, or the sensor is used for controlling the constriction deviceand/or stimulation device provided that the clock mechanism does notoverride the sensor. Suitably, the control device produces anindication, such as a sound signal or displayed information, in responseto signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's tissue wall portion, and the constrictionand stimulation devices form a constriction/stimulation unit.Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of a tissue wall portion of apatient's organ, and the stimulation device of the unit comprises aplurality of stimulation elements provided on and distributed along thecontact surfaces. When the control device controls the stimulationdevice to stimulate the wall portion, the stimulation elements stimulatedifferent areas of the wall portion along the length of the wallportion. The stimulation elements preferably comprise electric elements,as described above, for stimulating the wall portion with electricpulses. However, in most applications of the present invention, otherkinds of stimulations, such as thermal stimulation, could be suitable toemploy.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the organ, and the operation deviceoperates the clamping elements to clamp the wall portion between theclamping elements to constrict the wall portion of the organ.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the organ, and the operation device operates the clampingelement to clamp the wall portion between the clamping element and thebone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of theorgan, and the operation device rotates the engagement elements, suchthat the engagement elements engage and constrict the wall portion ofthe organ.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the organ, and the operation device moves the clamping elementstowards each other to clamp the wall portion of the organ between theclamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around theorgan, wherein the loop defines a constriction opening. The operationdevice operates the constriction member in the loop to change the sizeof the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

7) The constriction device is adapted to bend the wall portion of theorgan to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict said length of the tissuewall portion of the patient's organ. For this purpose, the constrictiondevice may include two or more of the described constrictionelements/members to be applied in a row along said length of the wallportion, wherein said row extends in the direction of flow in the lumenof the organ. Preferably, such constriction elements/members arenon-inflatable and mechanically operable or adjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the lumen assumes a size in the constrictedstate that enables the stimulation device to contract the wall portionsuch that the flow in the lumen is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the tissuewall portion of the patient's organ, so that the patient's wall portionis constricted upon expansion of the cavity and released uponcontraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

-   -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members is        operable by magnetic means, hydraulic means, or electric control        means.

2b) The apparatus comprises a fluid conduit between the pump and thecavity, wherein the reservoir forms part of the conduit. The conduit andpump are devoid of any non-return valve. The reservoir forms a fluidchamber with a variable volume, and the pump distributes fluid from thechamber to the cavity by a reduction in the volume of the chamber andwithdraws fluid from the cavity by an expansion of the volume of thechamber. The apparatus further comprises a motor for driving the pump,wherein the pump comprises a movable wall of the reservoir for changingthe volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of theorgan. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth, and the hydraulic means may also includea pump and an implantable reservoir containing hydraulic fluid. The pumpdistributes hydraulic fluid from the reservoir to the chambers to movethe clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling a flow of fluid and/or other bodily matter ina lumen formed by a tissue wall of a patient's organ, wherein theapparatus comprises an implantable constriction device for gentlyconstricting a portion of the tissue wall to influence the flow in thelumen, a stimulation device for intermittently and individuallystimulating different areas of the wall portion, as the constrictiondevice constricts the wall portion, to cause contraction of the wallportion to further influence the flow in the lumen, wherein theconstriction and stimulation devices form an operableconstriction/stimulation unit, a source of energy, and a control deviceoperable from outside the patient's body to control the source of energyto release energy for use in connection with the operation of theconstriction/stimulation unit. In a simple form of the invention, thesource of energy, such as a battery or accumulator, is implantable inthe patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

The above-described apparatus of the invention is suited for treatingdysfunctions of an organ of a human being or animal. For example, fortreating urinary and anal incontinence, constipation and impotence. Theapparatus of the invention is also suited for treating obesity orgallstone troubles, and for controlling blood flow in a blood vessel orthe release of eggs into a female's uterus.

Where the apparatus is used for controlling the food flow through thestomach of a patient, the apparatus comprises an implantableconstriction device for gently constricting at least one portion of thetissue wall of the patient's stomach to influence the food flow in thestomach, a stimulation device for stimulating the wall portion of thetissue wall, and a control device for controlling said stimulationdevice to stimulate the wall portion, as said constriction deviceconstricts the wall portion, to cause contraction of the wall portion tofurther influence the food flow in the stomach.

Where the apparatus is used for controlling the flow of intestinalcontents in the intestines of a patient, the apparatus comprises animplantable constriction device for gently constricting at least oneportion of the tissue wall of the patient's intestines to influence theflow of intestinal contents in the intestines, a stimulation device forstimulating the wall portion of the tissue wall, and a control devicefor controlling said stimulation device to stimulate the wall portion,as said constriction device constricts the wall portion, to causecontraction of the wall portion to further influence the flow ofintestinal contents in the intestines.

Where the apparatus is used for controlling the flow of urine in theurethra or urine bladder of a patient, the apparatus comprises animplantable constriction device for gently constricting at least oneportion of the tissue wall of the patient's urethra or urine bladder toinfluence the urine flow in the urethra or urine bladder, a stimulationdevice for stimulating the wall portion of the tissue wall, and acontrol device for controlling said stimulation device to stimulate thewall portion, as said constriction device constricts the wall portion,to cause contraction of the wall portion to further influence the urineflow in the urethra or urine bladder.

Where the apparatus is used as an impotence treatment apparatus, itcomprises a constriction device implantable in a male impotent patientfor gently constricting at least one penile portion of the patient'snormal penile tissue or the prolongation thereof, an implantablestimulation device for stimulating the penile portion, and a controldevice for controlling said stimulation device to stimulate the penileportion, as said constriction device constricts the penile portion, tocause contraction of the penile portion to restrict the blood flowleaving the penis to achieve erection. The term “normal penile tissue”is to be understood as excluding implanted tissue. Thus, the normalpenile tissue includes one or both of the corpora cavernosa and thecorpus spongiosum. The term “prolongation thereof” includes thebulbospongious and adjacent area.

Alternatively, the impotence treatment apparatus comprises aconstriction device implantable in a male impotent patient for gentlyconstricting at least one penile portion of the patient's normal peniletissue or the prolongation thereof to restrict the blood flow leavingthe penis, an implantable stimulation device for stimulating the penileportion as said constriction device constricts the penile portion, and acontrol device for controlling said stimulation device to stimulate thepenile portion, as said constriction device constricts the penileportion, to cause contraction of the penile portion to further restrictthe blood flow leaving the penis to achieve erection.

Alternatively, impotence treatment apparatus comprises a stimulationdevice implantable in a male impotent patient for stimulating at leastone penile portion of the patient's normal penile tissue or theprolongation thereof, and a control device for controlling saidstimulation device to stimulate the penile portion to cause contractionthereof to restrict the blood flow leaving the penis to achieveerection.

Where the apparatus is used for controlling the blood flow in a bloodvessel of a patient, the apparatus comprises an implantable constrictiondevice for gently constricting at least one portion of the tissue wallof the blood vessel to influence the blood flow in the blood vessel, astimulation device for stimulating the tissue wall portion, and acontrol device for controlling said stimulation device to stimulate thetissue wall portion as said constriction device constricts the tissuewall portion to cause contraction of the tissue wall portion to furtherinfluence the blood flow in the blood vessel.

Where the a apparatus is used for controlling the flow of eggs into theuterus of a female, the apparatus comprises an implantable constrictiondevice for constricting each one of the female's uterine tubes torestrict the passageway thereof, and a control device for controllingsaid constriction device to constrict the uterine tube such that an eggappearing in the passageway of the uterine tube is prevented fromentering the uterine cavity, and to release the uterine tube such thatan egg existing in the passageway of the uterine tube is allowed toenter the uterine cavity. The constriction device may gently constrictat least one portion of the tissue wall of the uterine tube to restrictthe passageway thereof, and an implantable stimulation device may beprovided for stimulating the tissue wall portion, wherein the controldevice controls said stimulation device to stimulate the tissue wallportion, as said constriction device constricts the tissue wall portion,to cause contraction of the tissue wall portion to further restrict thepassageway of the uterine tube.

Alternatively, the egg flow control apparatus comprises an implantableconstriction device for gently constricting at least one portion of thetissue wall of each one of the female's uterine tubes to restrict thepassageway thereof, a stimulation device for stimulating the tissue wallportion of the uterine tube, and a control device for controlling saidstimulation device to stimulate the tissue wall portion, as saidconstriction device constricts the tissue wall portion, to causecontraction of the tissue wall portion to further restrict thepassageway of the uterine tube to prevent an egg existing in the uterinetube from entering the uterine cavity.

Alternatively, the egg flow control apparatus comprises an implantablestimulation device for stimulating a portion of the tissue wall of eachone of the female's uterine tubes, and a control device for controllingsaid stimulation device to stimulate the tissue wall portion of theuterine tube to cause contraction of the tissue wall portion, such thatthe passageway of the uterine tube is restricted to prevent an eggappearing in the uterine tube from entering the uterine cavity, and tocease stimulating the tissue wall portion of the uterine tube to allowan egg existing in the passageway of the uterine tube to enter theuterine cavity.

Where the apparatus is used for controlling the flow of gallstones in apatient suffering from gallstone trouble, the apparatus comprises animplantable stimulation device for stimulating a portion of the tissuewall of the patient's cystic, hepatic or bile duct, and a control devicefor controlling said stimulation device to progressively stimulate thetissue wall portion to cause progressive contraction of the tissue wallportion to move one or more gallstones appearing in the duct in thedirection towards the duodenum.

The present invention also provides a method for using an apparatus asdescribed above to control a flow of fluid and/or other bodily matter ina lumen formed by a tissue wall of a patient's organ, the methodcomprising:

-   -   providing a wireless remote control adapted to control the        constriction device and/or stimulation device from outside the        patient's body, and    -   operating the wireless remote control by the patient, when the        patient wants to influence the flow of fluid and/or other bodily        matter in the lumen.

The present invention also provides a method for controlling a flow offluid and/or other bodily matter in a lumen formed by a tissue wall of apatient's organ, the method comprising:

a) gently constricting at least one portion of the tissue wall toinfluence the flow in the lumen, and

b) stimulating the constricted wall portion to cause contraction of thewall portion to further influence the flow in the lumen.

Intestinal Dysfunction

Another object of the present invention is to provide an apparatus forcontrolling the flow of intestinal contents in the intestinal passagewayformed by the tissue walls of a patient's intestines, so as to at leastsubstantially or even completely eliminate the injured tissue wallproblems that have resulted from implanted prior art devices thatconstrict similar bodily organs.

In accordance with this object of the present invention, there isprovided an apparatus for controlling the flow of intestinal contents inthe intestinal passageway of a patient's intestines, the apparatuscomprising an implantable constriction device for gently constricting aportion of the tissue wall of the intestines to influence the flow inthe intestinal passageway, a stimulation device for stimulating the wallportion of the tissue wall, and a control device for controlling thestimulation device to stimulate the wall portion as the constrictiondevice constricts the wall portion to cause contraction of the wallportion to further influence the flow in the intestinal passageway.

The present invention provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stageinfluence on the flow of intestinal contents in the intestinalpassageway of the intestines. Thus, the constriction device may gentlyconstrict the tissue wall by applying a relatively weak force againstthe wall portion, and the stimulation device may stimulate theconstricted wall portion to achieve the desired final influence on theflow of intestinal contents. The phrase “gently constricting a portionof the tissue wall” is to be understood as constricting the wall portionwithout substantially hampering the blood circulation in the tissue wallof the intestines.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the intestines allows tissue of the wall portion tomaintain substantially normal blood circulation during the operation ofthe apparatus of the invention.

The combination of the constriction and stimulation devices enablesapplication of the apparatus of the invention at any place on theintestines, which is a significant advance in the art, as compared withprior stimulation devices that are confined to electric stimulation ofmalfunctioning anal sphincters.

In most applications using the present invention, there will be dailyadjustments of the implanted constriction device. Therefore, in apreferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionas desired, wherein the control device controls the constriction deviceto adjust the constriction of the wall portion. The control device maycontrol the constriction and stimulation devices independently of eachother, and simultaneously. Optionally, the control device may controlthe stimulation device to stimulate, or to not stimulate the wallportion while the control device controls the constriction device tochange the constriction of the wall portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow of intestinal contents in the intestinal passageway is obtained.

Flow Restriction

The apparatus of the present invention is well suited for restrictingthe flow of intestinal contents in the intestinal passageway of theintestines. Thus, in a principal embodiment of the invention, theconstriction device is adapted to constrict the wall portion to at leastrestrict the flow of intestinal contents, and the control devicecontrols the stimulation device to cause contraction of the constrictedwall portion, so that the flow of intestinal contents in the intestinalpassageway is at least further restricted. Specifically, theconstriction device is adapted to constrict the wall portion to aconstricted state in which the blood circulation in the constricted wallportion is substantially unrestricted and the flow of intestinalcontents is at least restricted, and the control device controls thestimulation device to cause contraction of the wall portion, so that theflow of intestinal contents is at least further restricted when the wallportion is kept by the constriction device in the constricted state.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the wall portion, such that flow of intestinal contents isrestricted but not stopped, and controls the stimulation device tostimulate the constricted wall portion to cause contraction thereof,such that flow of intestinal contents is further restricted but notstopped. More precisely, the control device may control the stimulationdevice in a first mode to stimulate the constricted wall portion tofurther restrict but not stop the flow of intestinal contents and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the flow of intestinalcontents; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow of intestinal contents.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat flow of intestinal contents is restricted but not stopped, andcontrols the stimulation device to stimulate the constricted wallportion to cause contraction thereof, such that flow of intestinalcontents is stopped. More precisely, the control device may control thestimulation device in a first mode to stimulate the constricted wallportion to further restrict but not stop the flow of Intestinal contentsand to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow of intestinal contents inthe intestinal passageway; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow of intestinal contents.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow of intestinal contents is substantially stopped, andcontrols the stimulation device to stimulate the constricted wallportion to cause contraction thereof, such that the flow of intestinalcontents is completely stopped. More precisely, the control device maycontrol the stimulation device in a first mode to stimulate theconstricted wall portion to completely stop the flow of intestinalcontents and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow of intestinal contents; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow of intestinal contents.

The third flow restriction option is well suited for treating an analincontinent patient. Thus, the restriction and stimulation devices maybe implanted on any part of the anal incontinent patient's large orsmall intestines to serve as an artificial anal sphincter. Betweendefecations, the control device controls the constriction device togently flatten a portion of the intestines to at least almost completelystop the flow of intestinal contents in the intestinal passageway, andcontrols the stimulation device to stimulate the flattened portion toinsure that the flow of intestinal contents is completely stopped. Sincethe control device controls the stimulation device to intermittently andindividually stimulate the areas of the wall portion, as stated above,the risk of the implanted constriction device injuring the intestinesover time is significantly reduced or even eliminated, and it is insuredthat the effect of the stimulation is maintained over time. When thepatient wants to defecate, the control device controls the constrictionand stimulation devices to release the portion of the intestines andcease the stimulation, whereby intestinal contents may pass the portionof the intestines

Where the stimulation device stimulates the constricted wall portion tocontract, such that the flow of intestinal contents is stopped, thecontrol device suitably controls the stimulation device tosimultaneously and cyclically stimulate a first length of theconstricted wall portion and a second length of the constricted wallportion, which is located downstream of the first length, wherein thecontrol device controls the stimulation device to progressivelystimulate the first length in the upstream direction of the intestinalpassageway and to progressively stimulate the second length in thedownstream direction of the intestinal passageway.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the intestinal passageway,such that the flow of intestinal contents remains stopped. Any sensorfor sensing a physical parameter of the patient, such as a pressure inthe patient's body that relates to the pressure in the intestinalpassageway may be provided, wherein the control device controls thestimulation device in response to signals from the sensor. Such a sensormay for example sense the pressure in the patient's abdomen, thepressure against the implanted constriction device or the pressure onthe tissue wall of the intestines.

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow of intestinal contents is stopped. More precisely, thecontrol device may control the constriction device in a first mode toconstrict the constricted wall portion to stop the flow of intestinalcontents and in a second mode to cease the constriction of the wallportion to restore flow of intestinal contents. In this case, thecontrol device only controls the stimulation device to stimulate thewall portion when needed. A sensor for sensing a physical parameter ofthe patient's body that relates to the pressure in the intestinalpassageway may be provided, wherein the control device controls thestimulation device in response to signals from the sensor. Such aphysical parameter may be a pressure in the patient's abdomen and thesensor may be a pressure sensor.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the patient's wall portion of theintestines in the constricted state. In this case, the control devicemay be used when needed, conveniently by the patient, to control thestimulation device to stimulate the constricted tissue wall portion,preferably while adjusting the stimulation intensity, to causecontraction of the wall portion, such that the flow of intestinalcontents is at least further restricted or stopped, and to control thestimulation device to cease the stimulation. More precisely, the controldevice may:

a) control the stimulation device in a first mode to stimulate theconstricted wall portion to further restrict the flow of intestinalcontents, and control the stimulation device in a second mode to ceasethe stimulation of the wall portion to increase the flow of intestinalcontents; or

b) control the stimulation device in a first mode to stimulate theconstricted wall portion to stop the flow of intestinal contents, andcontrol the stimulation device in a second mode to cease the stimulationof the wall portion to allow flow of intestinal contents.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions of the intestines tissue wall of the intestines, respectively.The control device may control the constriction device to activate theconstriction elements in random or in accordance with a predeterminedsequence. In this case, the stimulation device includes stimulationelements positioned on the constriction elements, wherein the controldevice controls the stimulation device to activate the stimulationelements to stimulate any wall portions of the series of wall portionsconstricted by said constriction elements to contract the intestines toclose the intestinal passageway.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence toclose the intestinal passageway. The design of the constriction devicein the form of a plurality of separate constriction elements makespossible to counteract growth of hard fibrosis where the constrictiondevice is implanted.

Movement of Intestinal Contents in the Intestinal Passageway

As mentioned above, the apparatus of the invention can also be used fortreating patients suffering from constipation or reduced peristalticmuscle contractions of the intestines. Thus, as described in theembodiments of the invention listed below, the intestinal contents isactively moved in the intestinal passageway.

1) The control device controls the constriction device to close theintestinal passageway, either at an upstream end or a downstream end ofthe wall portion, and then controls the constriction device to constrictthe remaining part of the wall portion to move the fluid and/or otherbodily matter in the intestinal passageway.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the flowof intestinal contents. The control device controls the stimulationdevice to stimulate the wall portion constricted by the constrictiondevice to close the intestinal passageway, either at an upstream end ora downstream end of the wall portion, and simultaneously controls theconstriction device to increase the constriction of the wall portion tomove the intestinal contents in the intestinal passageway.

2) The constriction device is adapted to constrict the wall portion torestrict or vary the flow in the intestinal passageway, and the controldevice controls the stimulation device to progressively stimulate theconstricted wall portion, in the downstream or upstream direction of theintestinal passageway, to cause progressive contraction of the wallportion to move the intestinal contents in the intestinal passageway.

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion, such that thewall portion is progressively constricted in the downstream or upstreamdirection of the intestinal passageway to move the intestinal contentsin the intestinal passageway. The constriction device may include atleast one elongated constriction element that extends along the wallportion, wherein the control device controls the elongated constrictionelement to progressively constrict the wall portion in the downstream orupstream direction of the intestinal passageway.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the intestinal passageway. Suitably,the elongated constriction element comprises contact surfacesdimensioned to contact a length of the wall portion, when theconstriction device constricts the wall portion, and the stimulationdevice comprises a plurality of stimulation elements distributed alongthe contact surfaces, such that the stimulation elements stimulate thedifferent areas of the wall portion along the length of the wallportion, when the control device controls the stimulation device tostimulate the wall portion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to at least restrict the flow ofintestinal contents. The control device controls the constriction deviceto successively constrict the wall portions of the series of wallportions to move the intestinal contents in the intestinal passageway ina peristaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the tissue wall, respectively.The control device controls the constriction device to activate theconstriction elements one after the other, so that the wall portions ofthe series of wall portions are successively constricted along theintestines, whereby the intestinal contents is moved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the intestines to successively constrict thewall portions of the series of wall portions, wherein the control devicecontrols the constriction device to cyclically move the constrictionelement along the wall portions of the series of wall portions.Preferably, the constriction device comprises a plurality ofconstriction elements, each of which is moveable along the wall of theintestines to successively constrict the wall portions of the series ofwall portions, wherein the control device controls the constrictiondevice to cyclically move the constriction elements one after the otheralong the wall portions of the series of wall portions. Specifically,the constriction device includes a rotor carrying the constrictionelements, and the control device controls the rotor to rotate, such thateach constriction element cyclically constricts the wall portions of theseries of wall portions. Each constriction element suitably comprises aroller for rolling on the wall of the intestines to constrict thelatter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the intestinal passageway. Where the constrictiondevice includes at least one constriction element, the stimulationdevice suitably includes at least one stimulation element positioned onthe constriction element for stimulating the wall portion constricted bythe constriction element to close the intestinal passageway.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close theintestinal passageway.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to restrict the flow of intestinalcontents, wherein the constriction device includes a plurality ofconstriction elements adapted to constrict the wall portions of thetissue wall, respectively, and the stimulation device includesstimulation elements positioned on the constriction elements forstimulating the wall portions constricted by the constriction elementsto close the intestinal passageway. The control device controls theconstriction device to activate the constriction elements to constrictthe wall portions of the series of wall portions without completelyclosing the intestinal passageway, and controls the stimulation deviceto activate the stimulation elements to stimulate the wall portions oneafter the other, so that the wall portions of the series of wallportions are successively contracted along the intestines to move theintestinal contents in the intestinal passageway.

6) The constriction device comprises a first constriction element forconstricting the wall portion at an upstream end thereof, a secondconstriction element for constricting the wall portion at a downstreamend thereof, and a third constriction element for constricting the wallportion between the upstream and downstream ends thereof. The controldevice controls the first, second and third constriction elements toconstrict and release the wall portion independently of one another.More specifically, the control device controls the first or secondconstriction element to constrict the wall portion at the upstream ordownstream end thereof to close the intestinal passageway, and controlsthe third constriction element to constrict the wall portion between theupstream and downstream ends thereof, whereby the intestinal contentscontained in the wall portion between the upstream and downstream endsthereof is moved downstream or upstream in the intestinal passageway.Optionally, the control device controls the stimulation device tostimulate the wall portion between the upstream and downstream endsthereof, when the third constriction element constricts the wallportion.

-   -   6a) In accordance with a first alternative, the control device        controls the first constriction element to constrict the wall        portion at the upstream end thereof to restrict the flow in the        intestinal passageway and controls the stimulation device to        stimulate the constricted wall portion at the upstream end to        close the intestinal passageway. With the intestinal passageway        closed at the upstream end of the constricted wall portion, the        control device controls the third constriction element to        constrict the wall portion between the upstream and downstream        ends thereof, and optionally controls the stimulation device to        simultaneously stimulate the wall portion as the latter is        constricted by the third constriction element. As a result, the        intestinal contents contained in the wall portion between the        upstream and downstream ends thereof is moved downstream in the        intestinal passageway.    -   6b) In accordance with a second alternative, the control device        controls the second constriction element to constrict the wall        portion at the downstream end thereof to restrict the flow of        intestinal contents and controls the stimulation device to        stimulate the constricted wall portion at the downstream end to        close the intestinal passageway. With the intestinal passageway        closed at the downstream end of the constricted wall portion,        the control device controls the third constriction element to        constrict the wall portion between the upstream and downstream        ends thereof, and optionally controls the stimulation device to        simultaneously stimulate the wall portion as the latter is        constricted by the third constriction element. As a result, the        intestinal contents contained in the wall portion between the        upstream and downstream ends thereof is moved upstream in the        intestinal passageway.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion with electric pulses.

Where the apparatus controls the flow of intestinal contents in thesmall intestines, a particularly long wall portion of the smallintestines may be surgically prepared to extend in zigzag with adjacentwalls stitched together by two parallel rows of stitches and with theadjacent walls cut through between the two rows of stitches. As aresult, the intestinal passageway of this long wall portion of the smallintestines can be significantly expanded. In this case, the constrictiondevice of the apparatus of the invention is able to move a considerablylarger volume of intestinal contents each time it constricts the longwall portion of the small intestines.

The various solutions described above under the headline: “Flowrestriction” to stop the flow in the intestinal passageway may also beused in any of the above noted embodiments (1a), (1b), (4a), (5), (6),(6a) and (6b).

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of theintestines, such that at least two of the areas are stimulated atdifferent points of time that is, the stimulation is shifted from onearea to another area over time. In addition, the control device controlsthe stimulation device, such that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before the stimulation device stimulates the areaagain. Furthermore, the control device controls the stimulation deviceto stimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the intestines to achieve the desired flow control,while essentially maintaining over time the natural physical propertiesof the intestines without risking injuring the intestines.

Also, by physically changing the places of stimulation on the intestinesover time as described above it is possible to create an advantageouschanging stimulation pattern on the intestines, in order to achieve adesired flow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall during the stimulation thereof, the controldevice may control the stimulation device to, preferably cyclically,vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with said second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue wall portion of the patient'sintestines, preferably with electric pulses. This embodiment isparticularly suited for applications in which the wall portion includesmuscle fibers that react to electrical stimula. In this embodiment, thecontrol device controls the stimulation device to stimulate the wallportion with electric pulses preferably in the form of electric pulsetrains, when the wall portion is in the constricted state, to causecontraction of the wall portion. Of course, the configuration of theelectric pulse trains may be similar to the above described pulse trainsand the control device may control the stimulation device toelectrically stimulate the different areas of the wall of the intestinesin the same manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the intestines, such that the elongate pattern ofelectrical elements extends lengthwise along the wall of the intestines,and the elements abut the respective areas of the wall portion. Theelongate pattern of electrical elements may include one or more rows ofelectrical elements extending lengthwise along the wall of theintestines. Each row of electrical elements may form a straight, helicalor zig-zag path of electrical elements, or any form of path. The controldevice may control the stimulation device to successively energize theelectrical elements longitudinally along the elongate pattern ofelectrical elements in a direction opposite to, or in the same directionas that of, the flow of intestinal contents in the intestinalpassageway.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. When the intestinesis to be kept closed for a relatively long time, for example during thenight, the control device may control the stimulation device to energizethe electrical elements, such that energized electrical elements formtwo waves of energized electrical elements that simultaneously advancefrom the center of the constricted wall portion in two oppositedirections towards both ends of the elongate pattern of electricalelements. Such waves of energized electrical elements can be repeatedover and over again without harming the intestines and without movingintestinal contents in any direction in the intestinal passageway.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's intestines. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's intestines, preferably substantially transverseto the flow direction in the intestinal passageway. In a thirdalternative, the elements of the group of energized electrical elementsmay form more than two paths of energized electrical elements extendingon different sides of the patient's intestines, preferably substantiallytransverse to the flow direction in the intestinal passageway.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's intestinesin the flow direction in the intestinal passageway. The electricalelements of each group of electrical elements may form a path ofelements extending at least in part around the patient's intestines. Ina first alternative, the electrical elements of each group of electricalelements may form more than two paths of elements extending on differentsides of the patient's intestines, preferably substantially transverseto the flow direction in the intestinal passageway. The control devicemay control the stimulation device to energize the groups of electricalelements in the series of groups in random, or in accordance with apredetermined pattern. Alternatively, the control device may control thestimulation device to successively energize the groups of electricalelements in the series of groups in a direction opposite to, or in thesame direction as that of, the flow in the intestinal passageway, or inboth said directions starting from a position substantially at thecenter of the constricted wall portion. For example, groups of energizedelectrical elements may form advancing waves of energized electricalelements, as described above; that is, the control device may controlthe stimulation device to energize the groups of electrical elements,such that energized electrical elements form two waves of energizedelectrical elements that simultaneously advance from the center of theconstricted wall portion in two opposite directions towards both ends ofthe elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's intestines such that theelongate pattern of electrical elements extends along the intestines inthe same direction as that of the flow in the intestinal passageway andthe elements abut the respective areas of the wall portion of theintestines.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the intestines. Thus, the control devicemay control the stimulation device to cool the wall portion, when thewall portion is constricted, to cause contraction of the wall portion.For example, the constriction device may constrict the wall portion toat least restrict the flow in the intestinal passageway, and the controldevice may control the stimulation device to cool the constricted wallportion to cause contraction thereof, such that the flow in theintestinal passageway is at least further restricted, or furtherrestricted but not stopped, or stopped. Alternatively, the controldevice may control the stimulation device to heat the wall portion, whenthe wall portion is constricted and contracted, to cause expansion ofthe wall portion. Where applicable, thermal stimulation may be practisedin any of the embodiments of the present invention, and the thermalstimulation may be controlled in response to various sensors, forexample strain, motion or pressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing motion, i.e. naturalcontractions, such as intestinal contractions, pressure sensors forsensing pressure in the intestinal passageway, strain sensors forsensing strain of the intestines, flow sensors for sensing flow ofintestinal contents, spectro-photometrical sensors, Ph-sensors forsensing acidity or alkalinity of the intestinal contents, oxygen-sensorssensors for sensing the oxygen content of the intestinal contents, orsensors for sensing the distribution of the stimulation on thestimulated intestines. Any conceivable sensors for sensing any otherkind of useful physical parameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the intestinal passageway, wherein the control device controls theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion of the intestines in response to thepressure sensor sensing a predetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion of the intestines in response to the time of day. For thatpurpose the control device may include a clock mechanism for controllingthe constriction device and/or stimulation device to change theconstriction of the patient's wall portion to increase or decrease theinfluence on the flow of intestinal contents during different timeperiods of the day. In case a sensor of any of the above-described typesfor sensing a physical or functional parameter is provided, either theclock mechanism is used for controlling the constriction device and/orstimulation device provided that the parameter sensed by the sensor doesnot override the clock mechanism, or the sensor is used for controllingthe constriction device and/or stimulation device provided that theclock mechanism does not override the sensor. Suitably, the controldevice produces an indication, such as a sound signal or displayedinformation, in response to signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's tissue wall portion of the intestines, andthe constriction and stimulation devices form a constriction/stimulationunit. Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of a tissue wall portion of theintestines, and the stimulation device of the unit comprises a pluralityof stimulation elements provided on and distributed along the contactsurfaces. When the control device controls the stimulation device tostimulate the wall portion, the stimulation elements stimulate differentareas of the wall portion along the length of the wall portion. Thestimulation elements preferably comprise electric elements, as describedabove, for stimulating the wall portion with electric pulses. However,in most of the embodiments of the present invention, other kinds ofstimulations could be suitable to employ.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the intestines, and the operation deviceoperates the clamping elements to clamp the wall portion between theclamping elements to constrict the wall portion of the intestines.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the intestines, and the operation device operates the clampingelement to clamp the wall portion between the clamping element and thebone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of theintestines, and the operation device rotates the engagement elements,such that the engagement elements engage and constrict the wall portionof the intestines.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the intestines, and the operation device moves the clamping elementstowards each other to clamp the wall portion of the intestines betweenthe clamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around theintestines, wherein the loop defines a constriction opening. Theoperation device operates the constriction member in the loop to changethe size of the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

7) The constriction device is adapted to bend the wall portion of theintestines to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict said length of the tissuewall portion of the patient's intestines. For this purpose, theconstriction device may include two or more of the describedconstriction elements/members to be applied in a row along said lengthof the wall portion, wherein said row extends in the direction of flowin the intestinal passageway. Preferably, such constrictionelements/members are non-inflatable and mechanically operable oradjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many embodiments of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the Intestinal passageway assumes a size in theconstricted state that enables the stimulation device to contract thewall portion such that the flow of intestinal contents is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the tissuewall portion of the patient's intestines, so that the patient's wallportion is constricted upon expansion of the cavity and released uponcontraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion of the intestines,so that the patient's wall portion is constricted upon contraction ofthe bellows and released upon expansion of the bellows. Thus, arelatively small addition of hydraulic fluid to the bellows causes arelatively large increase in the constriction of the wall portion. Sucha bellows may also be replaced by a suitably designed piston/cylindermechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

-   -   2a) The pump comprises a first activation member for activating        the pump to pump fluid from the reservoir to the cavity and a        second activation member for activating the pump to pump fluid        from the cavity to the reservoir.    -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members is        operable by magnetic means, hydraulic means, or electric control        means.

2b) The apparatus comprises a fluid conduit between the pump and thecavity, wherein the reservoir forms part of the conduit. The conduit andpump are devoid of any non-return valve. The reservoir forms a fluidchamber with a variable volume, and the pump distributes fluid from thechamber to the cavity by a reduction in the volume of the chamber andwithdraws fluid from the cavity by an expansion of the volume of thechamber. The apparatus further comprises a motor for driving the pump,wherein the pump comprises a movable wall of the reservoir for changingthe volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of theintestines. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth, and the hydraulic means may also includea pump and an implantable reservoir containing hydraulic fluid. The pumpdistributes hydraulic fluid from the reservoir to the chambers to movethe clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion of the intestines. The wireless remote control may compriseat least one external signal transmitter or transceiver and at least oneinternal signal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling the flow of intestinal contents in theintestinal passageway formed by the tissue wall of the patient'sintestines, wherein the apparatus comprises an implantable constrictiondevice for gently constricting a portion of the tissue wall to influencethe flow of intestinal contents, a stimulation device for intermittentlyand individually stimulating different areas of the wall portion, as theconstriction device constricts the wall portion, to cause contraction ofthe wall portion to further influence the flow of intestinal contents,wherein the constriction and stimulation devices form an operableconstriction/stimulation unit, a source of energy, and a control deviceoperable from outside the patient's body to control the source of energyto release energy for use in connection with the operation of theconstriction/stimulation unit. In a simple form of the invention, thesource of energy, such as a battery or accumulator, is implantable inthe patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

In accordance with another aspect of the present invention, there isprovided an apparatus for controlling the flow of intestinal contents inthe intestines of a patient, the apparatus comprising an implantablestimulation device for stimulating at least one portion of the tissuewall of the patient's intestines, and a control device for controllingthe stimulation device to stimulate the wall portion to causecontraction of the wall portion to influence the flow of intestinalcontents in the intestines. Thus, for some individuals it may suffice tostimulate the intestines to achieve continence or to cure constipation,whereby there is no need for applying the constriction device. Whereapplicable, any of the embodiments outlined in the appended claims couldbe applied in this apparatus that only includes the stimulation device.

The present invention also provides a method for using an apparatus asdescribed above to control the flow of intestinal contents in theintestinal passageway formed by the tissue wall of a patient'sintestines, the method comprising:

providing a wireless remote control adapted to control the constrictiondevice and/or stimulation device from outside the patient's body, and

operating the wireless remote control by the patient, when the patientwants to influence the flow of intestinal contents in the intestinalpassageway.

Urinary Dysfunction

Another object of the present invention is to provide an apparatus forcontrolling the flow of urine in urinary passageways formed by tissuewalls of the urethra, ureter, renal pelvis or bladder, so as to at leastsubstantially or even completely eliminate the injured tissue wallproblems that have resulted from implanted prior art devices thatconstrict such bodily organs.

In accordance with this object of the present invention, there isprovided an apparatus for controlling the flow of urine in a urinarypassageway formed by the tissue wall of the urethra, ureter, renalpelvis or bladder, the apparatus comprising an implantable constrictiondevice for gently constricting a portion of the tissue wall to influencethe flow of urine, a stimulation device for stimulating the wall portionof the tissue wall, and a control device for controlling the stimulationdevice to stimulate the wall portion as the constriction deviceconstricts the wall portion to cause contraction of the wall portion tofurther influence the flow of urine.

The present invention provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stageinfluence on the flow of urine. Thus, the constriction device may gentlyconstrict the tissue wall of the urethra, ureter, renal pelvis orbladder by applying a relatively weak force against the wall portion,and the stimulation device may stimulate the constricted wall portion toachieve the desired final influence on the flow of urine. The phrase“gently constricting a portion of the tissue wall” is to be understoodas constricting the wall portion without substantially hampering theblood circulation in the tissue wall of the urethra, ureter, renalpelvis or bladder.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the urethra, ureter, renal pelvis or bladder allowstissue of the wall portion to maintain substantially normal bloodcirculation during the operation of the apparatus of the invention.

The combination of the constriction and stimulation devices enablesapplication of the apparatus of the invention at any place on theurethra, ureter, renal pelvis or bladder, which is a significant advancein the art, as compared with prior stimulation devices that are confinedto electric stimulation of malfunctioning urethral sphincters.

In most applications using the present invention, there will be dailyadjustments of the implanted constriction device. Therefore, in apreferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionas desired, wherein the control device controls the constriction deviceto adjust the constriction of the wall portion. The control device maycontrol the constriction and stimulation devices independently of eachother, and simultaneously. Optionally, the control device may controlthe stimulation device to stimulate, or to not stimulate the wallportion while the control device controls the constriction device tochange the constriction of the wall portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow of urine is obtained.

Flow Restriction

The apparatus of the present invention is well suited for restrictingthe flow of urine in the urinary passageway. Thus, in a principalembodiment of the invention, the constriction device is adapted toconstrict the wall portion to at least restrict the flow of urine, andthe control device controls the stimulation device to cause contractionof the constricted wall portion, so that the flow of urine is at leastfurther restricted. Specifically, the constriction device is adapted toconstrict the wall portion to a constricted state in which the bloodcirculation in the constricted wall portion is substantiallyunrestricted and the flow of urine is at least restricted, and thecontrol device controls the stimulation device to cause contraction ofthe wall portion, so that the flow of urine is at least furtherrestricted when the wall portion is kept by the constriction device inthe constricted state.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the wall portion, such that flow of urine is restricted butnot stopped, and controls the stimulation device to stimulate theconstricted wall portion to cause contraction thereof, such that flow ofurine is further restricted but not stopped. More precisely, the controldevice may control the stimulation device in a first mode to stimulatethe constricted wall portion to further restrict but not stop the flowof urine and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the flow of urine; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow of urine.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat flow of urine is restricted but not stopped, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that flow of urine is stopped. More precisely,the control device may control the stimulation device in a first mode tostimulate the constricted wall portion to further restrict but not stopthe flow of urine and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow of urine; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow of urine.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow of urine is substantially stopped, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that the flow of urine is completely stopped.More precisely, the control device may control the stimulation device ina first mode to stimulate the constricted wall portion to completelystop the flow of urine and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow of urine; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow of urine.

The third flow restriction option is well suited for treating a urinarystress incontinent patient. Thus, the restriction and stimulationdevices may be implanted on the stress incontinent patient's urethra,ureter, renal pelvis or lower part of the bladder to serve as anartificial urethral sphincter. Between urinations, the control devicecontrols the constriction device to gently flatten a portion of theurethra, ureter, renal pelvis or bladder to at least almost completelystop the flow of urine in the urethra, and controls the stimulationdevice to stimulate the flattened portion to insure that the flow ofurine is completely stopped. Since the control device controls thestimulation device to intermittently and individually stimulate theareas of the wall portion, as stated above, the risk of the implantedconstriction device injuring the urethra, ureter, renal pelvis orbladder over time is significantly reduced or even eliminated, and it isinsured that the effect of the stimulation is maintained over time. Whenthe patient wants to urinate, the control device controls theconstriction and stimulation devices to release the portion of theurethra, ureter, renal pelvis or bladder and cease the stimulation,whereby urine may pass through the urethra. However, it should be notedthat in some cases it may suffice to just cease the stimulation toachieve flow of urine through the urethra.

Where the stimulation device stimulates the constricted wall portion tocontract, such that the flow of urine is stopped, the control devicesuitably controls the stimulation device to simultaneously andcyclically stimulate a first length of the constricted wall portion anda second length of the constricted wall portion, which is locateddownstream of the first length, wherein the control device controls thestimulation device to progressively stimulate the first length in theupstream direction of the urinary passageway and to progressivelystimulate the second length in the downstream direction of the urinarypassageway.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the urinary passageway, suchthat the flow of urine remains stopped. Any sensor for sensing aphysical parameter of the patient, such as a pressure in the patient'sbody that relates to the pressure in the urinary passageway may beprovided, wherein the control device controls the stimulation device inresponse to signals from the sensor. Such a sensor may for example sensethe pressure in the patient's abdomen, the pressure against theimplanted constriction device or the pressure on the tissue wall of theurethra, ureter, renal pelvis or bladder.

Where a pressure sensor is provided, the constriction device constrictsthe urethra, ureter, renal pelvis or urine bladder, such that the urineflow is substantially stopped, and the stimulation device stimulates theconstricted urethra, ureter, renal pelvis or urine bladder to causecontraction thereof to completely stop the urine flow. The controldevice controls the stimulation device to increase the stimulationintensity in response to signals from the pressure sensor sensing asudden increase in the pressure in the patient's bladder or abdominalcavity, whereby the urine flow remains stopped and the patient maintainscontinence. In this manner, the present invention insures that thepatient even is continent when he or she sneezes or coughs, or performsother physical activity that causes a sudden pressure increase in thepatients bladder/urinary tract.

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow of urine is stopped. More precisely, the control devicemay control the constriction device in a first mode to constrict theconstricted wall portion to stop the flow of urine and in a second modeto cease the constriction of the wall portion to restore flow of urine.In this case, the control device only controls the stimulation device tostimulate the wall portion when needed. A sensor for sensing a physicalparameter of the patient's body that relates to the pressure in theurinary passageway may be provided, wherein the control device controlsthe stimulation device in response to signals from the sensor. Such aphysical parameter may be a pressure in the patient's abdomen and thesensor may be a pressure sensor.

For example, the fourth flow restriction option may be applied where thepresent invention is used for controlling urine flow of a urinary stressor urge incontinent patient in a manner similar to the situationdescribed in the foregoing paragraph 0026. However, in this examplestimulation is only applied when necessary to maintain continence, Thus,the control device controls the stimulation device to stimulate theurethra, ureter, renal pelvis or urine bladder to cause contractionthereof in response to signals from the pressure sensor sensing a suddenincrease in the pressure in the patient's bladder or abdominal cavity,when the patient sneezes or coughs, or performs other physical activity.As a result, the urine flow remains stopped and the patient maintainscontinence.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the patient's wall portion of theurethra, ureter, renal pelvis or bladder in the constricted state. Inthis case, the control device may be used when needed, conveniently bythe patient, to control the stimulation device to stimulate theconstricted tissue wall portion, preferably while adjusting thestimulation intensity, to cause contraction of the wall portion, suchthat the flow of urine is at least further restricted or stopped, and tocontrol the stimulation device to cease the stimulation. More precisely,the control device may:

a) control the stimulation device in a first mode to stimulate theconstricted wall portion to further restrict the flow of urine, andcontrol the stimulation device in a second mode to cease the stimulationof the wall portion to increase the flow of urine; or

b) control the stimulation device in a first mode to stimulate theconstricted wall portion to stop the flow of urine, and control thestimulation device in a second mode to cease the stimulation of the wallportion to allow flow of urine.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions, respectively, of the tissue wall of the urethra, ureter, renalpelvis or bladder. The control device may control the constrictiondevice to activate the constriction elements in random or in accordancewith a predetermined sequence. In this case, the stimulation deviceincludes stimulation elements positioned on the constriction elements,wherein the control device controls the stimulation device to activatethe stimulation elements to stimulate any wall portions of the series ofwall portions constricted by said constriction elements to contract theurethra, ureter, renal pelvis or bladder to close the urinarypassageway.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence toclose the urinary passageway. The design of the constriction device inthe form of a plurality of separate constriction elements makes possibleto counteract growth of hard fibrosis where the constriction device isimplanted.

Movement of Urine in the Urinary Passageway

The apparatus of the invention can be used for actively moving the urinein the urinary passageway of a urinary overflow incontinent patient, asdescribed in the embodiments of the invention listed below.

1) The control device controls the constriction device to close theurinary passageway, either at an upstream end or a downstream end of thewall portion, and then controls the constriction device to constrict theremaining part of the wall portion to move the urine in the urinarypassageway.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the flowof urine. The control device controls the stimulation device tostimulate the wall portion constricted by the constriction device toclose the urinary passageway, either at an upstream end or a downstreamend of the wall portion, and simultaneously controls the constrictiondevice to increase the constriction of the wall portion to move theurine in the urinary passageway.

2) The constriction device is adapted to constrict the wall portion torestrict or vary the flow of urine, and the control device controls thestimulation device to progressively stimulate the constricted wallportion, in the downstream or upstream direction of the urinarypassageway, to cause progressive contraction of the wall portion to movethe urine in the urinary passageway.

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion, such that thewall portion is progressively constricted in the downstream or upstreamdirection of the urinary passageway to move the urine in the urinarypassageway. The constriction device may include at least one elongatedconstriction element that extends along the wall portion, wherein thecontrol device controls the elongated constriction element toprogressively constrict the wall portion in the downstream or upstreamdirection of the lumen.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the urinary passageway. Suitably,the elongated constriction element comprises contact surfacesdimensioned to contact a length of the wall portion, when theconstriction device constricts the wall portion, and the stimulationdevice comprises a plurality of stimulation elements distributed alongthe contact surfaces, such that the stimulation elements stimulate thedifferent areas of the wall portion along the length of the wallportion, when the control device controls the stimulation device tostimulate the wall portion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to at least restrict the flow ofurine. The control device controls the constriction device tosuccessively constrict the wall portions of the series of wall portionsto move the urine in the urinary passageway in a peristaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the tissue wall, respectively.The control device controls the constriction device to activate theconstriction elements one after the other, so that the wall portions ofthe series of wall portions are successively constricted along theurethra, ureter, renal pelvis or bladder, whereby the urine in theurinary passageway is moved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the urethra, ureter, renal pelvis or bladderto successively constrict the wall portions of the series of wallportions, wherein the control device controls the constriction device tocyclically move the constriction element along the wall portions of theseries of wall portions. Preferably, the constriction device comprises aplurality of constriction elements, each of which is moveable along thewall of the urethra, ureter, renal pelvis or bladder to successivelyconstrict the wall portions of the series of wall portions, wherein thecontrol device controls the constriction device to cyclically move theconstriction elements one after the other along the wall portions of theseries of wall portions. Specifically, the constriction device includesa rotor carrying the constriction elements, and the control devicecontrols the rotor to rotate, such that each constriction elementcyclically constricts the wall portions of the series of wall portions.Each constriction element suitably comprises a roller for rolling on thewall of the urethra, ureter, renal pelvis or bladder to constrict thelatter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the urinary passageway. Where the constriction deviceincludes at least one constriction element, the stimulation devicesuitably includes at least one stimulation element positioned on theconstriction element for stimulating the wall portion constricted by theconstriction element to close the urinary passageway.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the urinarypassageway.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to restrict the flow of urine,wherein the constriction device includes a plurality of constrictionelements adapted to constrict the wall portions of the tissue wall,respectively, and the stimulation device includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the urinarypassageway. The control device controls the constriction device toactivate the constriction elements to constrict the wall portions of theseries of wall portions without completely closing the urinarypassageway, and controls the stimulation device to activate thestimulation elements to stimulate the wall portions one after the other,so that the wall portions of the series of wall portions aresuccessively contracted along the urethra, ureter, renal pelvis orbladder to move the urine in the urinary passageway.

6) The constriction device comprises a first constriction element forconstricting the wall portion at an upstream end thereof, a secondconstriction element for constricting the wall portion at a downstreamend thereof, and a third constriction element for constricting the wallportion between the upstream and downstream ends thereof. The controldevice controls the first, second and third constriction elements toconstrict and release the wall portion independently of one another.More specifically, the control device controls the first or secondconstriction element to constrict the wall portion at the upstream ordownstream end thereof to close the urinary passageway, and controls thethird constriction element to constrict the wall portion between theupstream and downstream ends thereof, whereby the urine contained in thewall portion between the upstream and downstream ends thereof is moveddownstream or upstream in the urinary passageway. Optionally, thecontrol device controls the stimulation device to stimulate the wallportion between the upstream and downstream ends thereof, when the thirdconstriction element constricts the wall portion.

-   -   6a) In accordance with a first alternative, the control device        controls the first constriction element to constrict the wall        portion at the upstream end thereof to restrict the flow of        urine and controls the stimulation device to stimulate the        constricted wall portion at the upstream end to close the        urinary passageway. With the urinary passageway closed at the        upstream end of the constricted wall portion, the control device        controls the third constriction element to constrict the wall        portion between the upstream and downstream ends thereof, and        optionally controls the stimulation device to simultaneously        stimulate the wall portion as the latter is constricted by the        third constriction element. As a result, the urine contained in        the wall portion between the upstream and downstream ends        thereof is moved downstream in the urinary passageway.    -   6b) In accordance with a second alternative, the control device        controls the second constriction element to constrict the wall        portion at the downstream end thereof to restrict the flow of        urine and controls the stimulation device to stimulate the        constricted wall portion at the downstream end to close the        urinary passageway. With the urinary passageway closed at the        downstream end of the constricted wall portion, the control        device controls the third constriction element to constrict the        wall portion between the upstream and downstream ends thereof,        and optionally controls the stimulation device to simultaneously        stimulate the wall portion as the latter is constricted by the        third constriction element. As a result, the urine contained in        the wall portion between the upstream and downstream ends        thereof is moved upstream in the urinary passageway.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion with electric pulses.

The various solutions described above under the headline: “Flowrestriction” to stop the flow of urine of the organ may also be used inany of the above noted embodiments (1a), (1b), (4a), (5), (6), (6a) and(6b).

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of theurethra, ureter, renal pelvis or bladder, such that at least two of theareas are stimulated at different points of time that is, thestimulation is shifted from one area to another area over time. Inaddition, the control device controls the stimulation device, such thatan area of the different areas that currently is not stimulated has timeto restore substantially normal blood circulation before the stimulationdevice stimulates the area again. Furthermore, the control devicecontrols the stimulation device to stimulate each area during successivetime periods, wherein each time period is short enough to maintainsatisfactory blood circulation in the area until the lapse of the timeperiod. This gives the advantage that the apparatus of the presentinvention enables continuous stimulation of the wall portion of theurethra, ureter, renal pelvis or bladder to achieve the desired flowcontrol, while essentially maintaining over time the natural physicalproperties of the urethra, ureter, renal pelvis or bladder withoutrisking injuring the urethra, ureter, renal pelvis or bladder.

Also, by physically changing the places of stimulation on the urethra,ureter, renal pelvis or bladder over time as described above it ispossible to create an advantageous changing stimulation pattern on theurethra, ureter, renal pelvis or bladder, in order to achieve a desiredflow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall during the stimulation thereof, the controldevice may control the stimulation device to, preferably cyclically,vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with said second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue wall portion of the patient'surethra, ureter, renal pelvis or bladder, preferably with electricpulses. This embodiment is particularly suited for applications in whichthe wall portion includes muscle fibers that react to electricalstimula. In this embodiment, the control device controls the stimulationdevice to stimulate the wall portion with electric pulses preferably inthe form of electric pulse trains, when the wall portion is in theconstricted state, to cause contraction of the wall portion. Of course,the configuration of the electric pulse trains may be similar to theabove described pulse trains and the control device may control thestimulation device to electrically stimulate the different areas of thewall of the urethra, ureter, renal pelvis or bladder in the same manneras described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the urethra, ureter, renal pelvis or bladder, suchthat the elongate pattern of electrical elements extends lengthwisealong the wall of the urethra, ureter, renal pelvis or bladder, and theelements abut the respective areas of the wall portion. The elongatepattern of electrical elements may include one or more rows ofelectrical elements extending lengthwise along the wall of the urethra,ureter, renal pelvis or bladder. Each row of electrical elements mayform a straight, helical or zig-zag path of electrical elements, or anyform of path. The control device may control the stimulation device tosuccessively energize the electrical elements longitudinally along theelongate pattern of electrical elements in a direction opposite to, orin the same direction as that of the flow of urine.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. When the urinarypassageway is to be kept closed for a relatively long time, for exampleduring the night, the control device may control the stimulation deviceto energize the electrical elements, such that energized electricalelements form two waves of energized electrical elements thatsimultaneously advance from the center of the constricted wall portionin two opposite directions towards both ends of the elongate pattern ofelectrical elements. Such waves of energized electrical elements can berepeated over and over again without harming the urethra, ureter, renalpelvis or bladder and without moving urine in any direction in theurinary passageway.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's urethra, ureter, renalpelvis or bladder. In a second alternative, the elements of the group ofenergized electrical elements may form two paths of energized electricalelements extending on mutual sides of the patient's urethra, ureter,renal pelvis or bladder, preferably substantially transverse to the flowdirection in the urinary passageway. In a third alternative, theelements of the group of energized electrical elements may form morethan two paths of energized electrical elements extending on differentsides of the patient's urethra, ureter, renal pelvis or bladder,preferably substantially transverse to the flow direction in thepatient's urinary passageway.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's urethra,ureter, renal pelvis or bladder in the flow direction in the urinarypassageway. The electrical elements of each group of electrical elementsmay form a path of elements extending at least in part around thepatient's urethra, ureter, renal pelvis or bladder. In a firstalternative, the electrical elements of each group of electricalelements may form more than two paths of elements extending on differentsides of the patient's urethra, ureter, renal pelvis or bladder,preferably substantially transverse to the flow direction in thepatient's urinary passageway. The control device may control thestimulation device to energize the groups of electrical elements in theseries of groups in random, or in accordance with a predeterminedpattern. Alternatively, the control device may control the stimulationdevice to successively energize the groups of electrical elements in theseries of groups in a direction opposite to, or in the same direction asthat of, the flow in the patient's urinary passageway, or in both saiddirections starting from a position substantially at the center of theconstricted wall portion. For example, groups of energized electricalelements may form advancing waves of energized electrical elements, asdescribed above; that is, the control device may control the stimulationdevice to energize the groups of electrical elements, such thatenergized electrical elements form two waves of energized electricalelements that simultaneously advance from the center of the constrictedwall portion in two opposite directions towards both ends of theelongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's urethra, ureter, renalpelvis or bladder such that the elongate pattern of electrical elementsextends along the urethra, ureter, renal pelvis or bladder in the samedirection as that of the flow in the patient's urinary passageway andthe elements abut the respective areas of the wall portion of theurethra, ureter, renal pelvis or bladder.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the urethra, ureter, renal pelvis orbladder. Thus, the control device may control the stimulation device tocool the wall portion, when the wall portion is constricted, to causecontraction of the wall portion. For example, the constriction devicemay constrict the wall portion to at least restrict the flow of urine,and the control device may control the stimulation device to cool theconstricted wall portion to cause contraction thereof, such that theflow of urine is at least further restricted, or further restricted butnot stopped, or stopped. Alternatively, the control device may controlthe stimulation device to heat the wall portion, when the wall portionis constricted and contracted, to cause expansion of the wall portion.Where applicable, thermal stimulation may be practised in any of theembodiments of the present invention, and the thermal stimulation may becontrolled in response to various sensors, for example strain, motion orpressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing motion, i.e. naturalcontractions, such as bladder contractions, pressure sensors for sensingpressure in the urethra, ureter, renal pelvis or bladder, strain sensorsfor sensing strain of the urethra, ureter, renal pelvis or bladder, flowsensors for sensing flow of urine, spectro-photometrical sensors,Ph-sensors for sensing acidity or alkalinity of the urine in the urinarypassageway, oxygen-sensors sensors for sensing the oxygen content of theurine in the urinary passageway, or sensors for sensing the distributionof the stimulation on the stimulated urethra, ureter, renal pelvis orbladder. Any conceivable sensors for sensing any other kind of usefulphysical parameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the urinary passageway, wherein the control device controls theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion of the urethra, ureter, renal pelvis orbladder in response to the pressure sensor sensing a predetermined valueof measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion of the urethra, ureter, renal pelvis or bladder in response tothe time of day. For that purpose the control device may include a clockmechanism for controlling the constriction device and/or stimulationdevice to change the constriction of the patient's wall portion toincrease or decrease the influence on the flow of urine during differenttime periods of the day. In case a sensor of any of the above-describedtypes for sensing a physical or functional parameter is provided, eitherthe clock mechanism is used for controlling the constriction deviceand/or stimulation device provided that the parameter sensed by thesensor does not override the clock mechanism, or the sensor is used forcontrolling the constriction device and/or stimulation device providedthat the clock mechanism does not override the sensor. Suitably, thecontrol device produces an indication, such as a sound signal ordisplayed information, in response to signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's tissue wall portion of the urethra,ureter, renal pelvis or bladder, and the constriction and stimulationdevices form a constriction/stimulation unit Preferably, theconstriction and stimulation devices of the constriction/stimulationunit are integrated in a single piece suitable for implantation. Theconstriction device of the unit comprises contact surfaces dimensionedto contact a length of a tissue wall portion of the urethra, ureter,renal pelvis or bladder, and the stimulation device of the unitcomprises a plurality of stimulation elements provided on anddistributed along the contact surfaces. When the control device controlsthe stimulation device to stimulate the wall portion, the stimulationelements stimulate different areas of the wall portion along the lengthof the wall portion. The stimulation elements preferably compriseelectric elements, as described above, for stimulating the wall portionwith electric pulses. However, in most of the embodiments of the presentinvention, other kinds of stimulations could be suitable to employ.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the urethra, ureter, renal pelvis orbladder, and the operation device operates the clamping elements toclamp the wall portion between the clamping elements to constrict thewall portion of the urethra, ureter, renal pelvis or bladder.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the urethra, ureter, renal pelvis or bladder, and the operationdevice operates the clamping element to clamp the wall portion betweenthe clamping element and the bone or tissue of the patient to constrictthe wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of theurethra, ureter, renal pelvis or bladder, and the operation devicerotates the engagement elements, such that the engagement elementsengage and constrict the wall portion of the urethra, ureter, renalpelvis or bladder.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the urethra, ureter, renal pelvis or bladder, and the operationdevice moves the clamping elements towards each other to clamp the wallportion of the urethra, ureter, renal pelvis or bladder between theclamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around theurethra, ureter, renal pelvis or bladder, wherein the loop defines aconstriction opening. The operation device operates the constrictionmember in the loop to change the size of the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

7) The constriction device is adapted to bend the wall portion of theurethra, ureter, renal pelvis or bladder to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict said length of the tissuewall portion of the patient's urethra, ureter, renal pelvis or bladder.For this purpose, the constriction device may include two or more of thedescribed constriction elements/members to be applied in a row alongsaid length of the wall portion, wherein said row extends in thedirection of flow of urine of the organ. Preferably, such constrictionelements/members are non-inflatable and mechanically operable oradjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the lumen assumes a size in the constrictedstate that enables the stimulation device to contract the wall portionsuch that the flow of urine is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the tissuewall portion of the patient's urethra, ureter, renal pelvis or bladder,so that the patient's wall portion is constricted upon expansion of thecavity and released upon contraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion of the urethra,ureter, renal pelvis or bladder, so that the patient's wall portion isconstricted upon contraction of the bellows and released upon expansionof the bellows. Thus, a relatively small addition of hydraulic fluid tothe bellows causes a relatively large increase in the constriction ofthe wall portion. Such a bellows may also be replaced by a suitablydesigned piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

-   -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members is        operable by magnetic means, hydraulic means, or electric control        means.    -   2b) The apparatus comprises a fluid conduit between the pump and        the cavity, wherein the reservoir forms part of the conduit. The        conduit and pump are devoid of any non-return valve. The        reservoir forms a fluid chamber with a variable volume, and the        pump distributes fluid from the chamber to the cavity by a        reduction in the volume of the chamber and withdraws fluid from        the cavity by an expansion of the volume of the chamber. The        apparatus further comprises a motor for driving the pump,        wherein the pump comprises a movable wall of the reservoir for        changing the volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of theurethra, ureter, renal pelvis or bladder. The hydraulic means, which mayinclude the reverse servo described above, hydraulically moves theelongated clamping elements towards the wall portion to constrict thewall portion. For example, the constriction device may have hydraulicchambers in which the clamping elements slide back and forth, and thehydraulic means may also include a pump and an implantable reservoircontaining hydraulic fluid. The pump distributes hydraulic fluid fromthe reservoir to the chambers to move the clamping elements against thewall portion, and distributes hydraulic fluid from the chambers to thereservoir to move the clamping elements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion of the urethra, ureter, renal pelvis or bladder. Thewireless remote control may comprise at least one external signaltransmitter or transceiver and at least one internal signal receiver ortransceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling the flow of urine in the urinary passagewayformed by the tissue wall of the patient's urethra, ureter, renal pelvisor bladder, wherein the apparatus comprises an implantable constrictiondevice for gently constricting a portion of the tissue wall to influencethe flow of urine, a stimulation device for intermittently andindividually stimulating different areas of the wall portion, as theconstriction device constricts the wall portion, to cause contraction ofthe wall portion to further influence the flow of urine, wherein theconstriction and stimulation devices form an operableconstriction/stimulation unit, a source of energy, and a control deviceoperable from outside the patient's body to control the source of energyto release energy for use in connection with the operation of theconstriction/stimulation unit. In a simple form of the invention, thesource of energy, such as a battery or accumulator, is implantable inthe patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

In accordance with another aspect of the present invention, there isprovided an apparatus for controlling the flow of urine in the urethra,ureter, renal pelvis or urine bladder of a patient, the apparatuscomprising an implantable stimulation device for stimulating at leastone portion of the tissue wall of the patient's urethra, ureter, renalpelvis or urine bladder, and a control device for controlling thestimulation device to stimulate the wall portion to cause contraction ofthe wall portion to influence the flow of urine in the urethra, ureter,renal pelvis or urine bladder. Thus, for some individuals it may sufficeto stimulate the urethra, ureter, renal pelvis or urine bladder toachieve continence or to restore bladder function, whereby there is noneed for applying the constriction device. Where applicable, any of theembodiments outlined in the appended claims could be applied in thisapparatus that only includes the stimulation device.

The present invention also provides a method for using an apparatus asdescribed above to control the flow of urine in the urinary passagewayformed by the tissue wall of a patient's urethra, ureter, renal pelvisor bladder, the method comprising:

providing a wireless remote control adapted to control the constrictiondevice and/or stimulation device from outside the patient's body, and

operating the wireless remote control by the patient, when the patientwants to influence the flow of urine in the lumen.

Obesity

Another object of the present invention is to provide a versatilecareful apparatus for controlling the food flow in the stomach of anobese patient, so as to reduce the patient's weight while minimizing thecomplications previously associated with gastric restriction surgery.

In accordance with this object of the present invention, there isprovided an apparatus for controlling the food flow through the foodpassageway of the stomach of an obese patient, the stomach beingsurgically modified by the operation called Adjustable Gastric Banding(AGB). The apparatus comprises an implantable constriction device forgently constricting at least one portion of the tissue wall of thepatient's stomach to influence the food flow in the stomach, astimulation device for stimulating the wall portion of the tissue wall,and a control device for controlling the stimulation device to stimulatethe wall portion, as the constriction device constricts the wallportion, to cause contraction of the wall portion to further influencethe food flow in the stomach.

There is also provided an apparatus for controlling the food flow in thestomach of an obese patient surgically modified by any one of the groupof operations called Vertical Banded Gastroplasty, wherein the stomachis compartmentalized into a smaller proximal compartment adjacent theesophagus and a larger distal compartment, the smaller proximalcompartment communicating with the larger distal compartment via anarrow outlet opening. The apparatus comprises an implantableconstriction device for gently constricting at least one portion of thetissue wall of the patient's stomach to influence the food flow in afood passageway extending in the smaller proximal compartment throughthe narrow outlet opening, an implantable stimulation device forstimulating the wall portion of the tissue wall, and a control devicefor controlling the stimulation device to stimulate the wall portion, asthe constriction device constricts the wall portion, to causecontraction of the wall portion to further influence the food flow inthe food passageway.

The present invention provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stageinfluence on the food flow in the smaller compartment of the stomach.Thus, the constriction device may gently constrict the tissue wall ofthe stomach by applying a relatively weak force against the wallportion, and the stimulation device may stimulate the constricted wallportion to achieve the desired final influence on the food flow in thestomach. The phrase “gently constricting a portion of the tissue wall”is to be understood as constricting the wall portion withoutsubstantially hampering the blood circulation in the tissue wall.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion of the smaller compartment as the constrictiondevice constricts the wall portion, and the control device controls thestimulation device to intermittently and individually stimulate theareas of the wall portion. This intermittent and individual stimulationof different areas of the wall portion of the smaller compartment allowstissue of the wall portion to maintain substantially normal bloodcirculation during the operation of the apparatus of the invention.

In a preferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionof the smaller compartment as desired, wherein the control devicecontrols the constriction device to adjust the constriction of the wallportion. The control device may control the constriction and stimulationdevices independently of each other, and simultaneously. Optionally, thecontrol device may control the stimulation device to stimulate, or tonot stimulate the wall portion while the control device controls theconstriction device to change the constriction of the wall portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion of the smaller compartment, while controlling the constrictiondevice to adjust the constriction of the wall portion until the desiredrestriction of the food flow in the food passageway is obtained.

Flow Restriction

The apparatus of the present invention is well suited for restrictingthe food flow in the food passageway of the stomach of an obese AGB orVBG treated patient. Thus, in a principal embodiment of the invention,as for an AGB treated patient, the constriction device is adapted toconstrict the wall portion of the stomach to at least restrict the foodflow in the food passageway, and the control device controls thestimulation device to cause contraction of the constricted wall portion,so that the food flow in the food passageway is at least furtherrestricted. As for a VBG treated patient, the constriction device isadapted to constrict the wall portion of the smaller compartment to forma size of the outlet opening that at least restricts the food flow inthe food passageway, and the control device controls the stimulationdevice to cause contraction of the constricted wall portion, such thatthe outlet opening is reduced to at least further restrict the food flowin the food passageway. The action of the stimulation device to furtherrestrict the food flow is much more careful to the patient's stomach ascompared with the situtation where the constriction device, for examplein the form of a traditional gastric band, alone constricts the stomachto the same final size of the stoma outlet opening. This carefultreatment of the obese patient's stomach in accordance with the presentinvention is a significant advance in the art. Specifically, theconstriction device is adapted to constrict the wall portion to aconstricted state in which the blood circulation in the constricted wallportion is substantially unrestricted and the food flow in the foodpassageway is at least restricted, and the control device controls thestimulation device to cause contraction of the wall portion, so that thefood flow in the food passageway is at least further restricted when thewall portion is kept by the constriction device in the constrictedstate.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the food flowrestriction that is desired to be achieved for an individual obesepatient. Thus, in accordance with a first flow restriction option, thecontrol device controls the constriction device to constrict the wallportion of the smaller compartment to form a size of the outlet openingthat restricts but does not stop the food flow in the food passageway,and controls the stimulation device to stimulate the constricted wallportion to cause contraction thereof, such that the outlet opening isreduced to further restrict but not stop the food flow in the foodpassageway. In this condition the outlet opening should be small enoughto cause rapid filling of the proximal smaller compartment with a smallamount of food, so that the patient senses fullness and stops to eat.More precisely, the control device may control the stimulation device ina first mode to stimulate the constricted wall portion to reduce theoutlet opening to further restrict but not stop the food flow in thefood passageway and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to enlarge the outlet opening to        increase the food flow in the food passageway; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the food flow in the food        passageway.

The control device is conveniently programmed to start the second modeafter the lapse of a predetermined time counted from the first mode.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the wall portion of thesmaller compartment to form a size of the outlet opening that restrictsbut does not stop the food flow in the food passageway, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that the outlet opening is closed to stop thefood flow in the food passageway. More precisely, the control device maycontrol the stimulation device in a first mode to stimulate theconstricted wall portion to further restrict but not stop the food flowin the food passageway and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to open the outlet opening to allow foodflow in the food passageway; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the food flow in the food passageway.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the wall portion of thesmaller compartment to form a size of the outlet opening thatsubstantially stops the food flow in the food passageway, and controlsthe stimulation device to stimulate the constricted wall portion tocause contraction thereof, such that the outlet opening is closed tocompletely stop the food flow in the food passageway. More precisely,the control device may control the stimulation device in a first mode tostimulate the constricted wall portion to completely stop the food flowin the food passageway and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to open the outlet opening to allow foodflow in the food passageway; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the food flow in the food passageway.

Where the stimulation device stimulates the constricted wall portion ofthe smaller compartment to contract, such that the food flow in the foodpassageway is stopped, the control device suitably controls thestimulation device to simultaneously and cyclically stimulate a firstlength of the constricted wall portion and a second length of theconstricted wall portion, which is located downstream of the firstlength, wherein the control device controls the stimulation device toprogressively stimulate the first length in the upstream direction ofthe food passageway and to progressively stimulate the second length inthe downstream direction of the food passageway.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the food passageway, such thatthe food flow in the food passageway remains stopped. Any sensor forsensing a physical parameter of the patient, such as a pressure in thepatient's body that relates to the pressure in the food passageway maybe provided, wherein the control device controls the stimulation devicein response to signals from the sensor. Such a sensor may for examplesense the pressure in the patient's abdomen, the pressure against theimplanted constriction device or the pressure on the tissue wall of thestomach.

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the wall portion of thesmaller compartment to close the outlet opening to stop the food flow inthe food passageway. More precisely, the control device may control theconstriction device in a first mode to constrict the constricted wallportion to stop the food flow in the food passageway and in a secondmode to cease the constriction of the wall portion to open the outletopening to restore food flow in the food passageway. In this case, thecontrol device only controls the stimulation device to stimulate thewall portion when needed. A sensor for sensing a physical parameter ofthe patient's body that relates to the pressure in the food passagewaymay be provided, wherein the control device controls the stimulationdevice in response to signals from the sensor. Such a physical parametermay be a pressure in the patient's abdomen and the sensor may be apressure sensor.

For some individual patients the implanted constriction device maysuitably be designed to normally keep the patient's wall portion of thesmaller compartment of the stomach between meals in a constricted state,in which the outlet opening has a predetermined relatively large size.In this case, the control device suitably controls the stimulationdevice in response to signals from a sensor sensing that the patient iseating to stimulate the constricted wall portion, preferably whileadjusting the stimulation intensity, to cause contraction of the wallportion, such that the outlet opening is reduced or closed to restrictor stop the food flow in the food passageway of the smaller compartment.Then, after the lapse of a predetermined time, the control device maycontrol the stimulation device to cease the stimulation to open theoutlet opening. To describe the options more precisely, the controldevice may:

a) control the stimulation device in a first mode to stimulate theconstricted wall portion to reduce the outlet opening to furtherrestrict the food flow in the food passageway, and control thestimulation device in a second mode to cease the stimulation of the wallportion to enlarge the outlet opening to increase the food flow in thefood passageway; or

b) control the stimulation device in a first mode to stimulate theconstricted wall portion to close the outlet opening to stop the foodflow in the food passageway, and control the stimulation device in asecond mode to cease the stimulation of the wall portion to open theoutlet opening to allow food flow in the food passageway.

The second mode suitably starts after the lapse of a predetermined timecounted from the first mode.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions, respectively, of the stomach wall defining the smallercompartment. The control device may control the constriction device toactivate the constriction elements in random or in accordance with apredetermined sequence. In this case, the stimulation device includesstimulation elements positioned on the constriction elements, whereinthe control device controls the stimulation device to activate thestimulation elements to stimulate any wall portions of the series ofwall portions constricted by the constriction elements to contract thestomach wall defining the smaller compartment.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions of the stomach wall defining the smallercompartment, and controls the stimulation device to activate thestimulation elements to stimulate any constricted wall portions inrandom or in accordance with a predetermined sequence to reduce or closethe outlet opening. The design of the constriction device in the form ofa plurality of separate constriction elements makes possible tocounteract growth of hard fibrosis where the constriction device engagesthe tissue wall of the stomach.

Movement of Food in the Smaller Compartment of Stomach

For some individual obese patients treated with VBG it may be beneficialto temporarily aid the transportation of food through the foodpassageway of the proximal smaller compartment. In such a case theapparatus of the invention can be used for actively moving the food inthe food passageway of the smaller compartment, as described in theembodiments of the invention listed below.

1) The control device controls the constriction device to close the foodpassageway, either at an upstream end or a downstream end of the wallportion of the smaller compartment, and then controls the constrictiondevice to constrict the remaining part of the wall portion to move thefood in the food passageway.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the foodflow in the food passageway. The control device controls the stimulationdevice to stimulate the wall portion constricted by the constrictiondevice to close the food passageway, either at an upstream end or adownstream end of the wall portion, and simultaneously controls theconstriction device to increase the constriction of the wall portion tomove the food in the food passageway.

2) The constriction device is adapted to constrict the wall portion ofthe smaller compartment to restrict or vary the food flow in the foodpassageway, and the control device controls the stimulation device toprogressively stimulate the constricted wall portion, in the downstreamor upstream direction of the food passageway, to cause progressivecontraction of the wall portion to move the food in the food passageway.

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion of the smallercompartment, such that the wall portion is progressively constricted inthe downstream or upstream direction of the food passageway to move thefood in the food passageway. The constriction device may include atleast one elongated constriction element that extends along the wallportion, wherein the control device controls the elongated constrictionelement to progressively constrict the wall portion in the downstream orupstream direction of the food passageway.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the food passageway. Suitably, theelongated constriction element comprises contact surfaces dimensioned tocontact a length of the wall portion, when the constriction deviceconstricts the wall portion, and the stimulation device comprises aplurality of stimulation elements distributed along the contactsurfaces, such that the stimulation elements stimulate the differentareas of the wall portion along the length of the wall portion, when thecontrol device controls the stimulation device to stimulate the wallportion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions, respectively, of the wall defining the smallercompartment to at least restrict the food flow in the food passageway.The control device controls the constriction device to successivelyconstrict the wall portions of the series of wall portions to move thefood in the food passageway in a peristaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the tissue wall, respectively.The control device controls the constriction device to activate theconstriction elements one after the other, so that the wall portions ofthe series of wall portions are successively constricted along thestomach, whereby the food in the food passageway is moved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the stomach to successively constrict thewall portions of the series of wall portions, wherein the control devicecontrols the constriction device to cyclically move the constrictionelement along the wall portions of the series of wall portions.Preferably, the constriction device comprises a plurality ofconstriction elements, each of which is moveable along the wall definingthe smaller compartment to successively constrict the wall portions ofthe series of wall portions, wherein the control device controls theconstriction device to cyclically move the constriction elements oneafter the other along the wall portions of the series of wall portions.Specifically, the constriction device includes a rotor carrying theconstriction elements, and the control device controls the rotor torotate, such that each constriction element cyclically constricts thewall portions of the series of wall portions. Each constriction elementsuitably comprises a roller for rolling on the wall defining the smallercompartment to constrict the latter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the food passageway. Where the constriction deviceincludes at least one constriction element, the stimulation devicesuitably includes at least one stimulation element positioned on theconstriction element for stimulating the wall portion constricted by theconstriction element to close the food passageway.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the foodpassageway of the smaller compartment.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the wall defining the smaller compartment torestrict the food flow in the food passageway, wherein the constrictiondevice includes a plurality of constriction elements adapted toconstrict the wall portions, respectively, and the stimulation deviceincludes stimulation elements positioned on the constriction elementsfor stimulating the wall portions constricted by the constrictionelements to close the food passageway. The control device controls theconstriction device to activate the constriction elements to constrictthe wall portions of the series of wall portions without completelyclosing the food passageway, and controls the stimulation device toactivate the stimulation elements to stimulate the wall portions oneafter the other, so that the wall portions of the series of wallportions are successively contracted along the stomach to move the foodin the food passageway of the smaller compartment.

6) The constriction device comprises a first constriction element forconstricting the wall portion of the smaller compartment at an upstreamend thereof, a second constriction element for constricting the wallportion at a downstream end thereof, and a third constriction elementfor constricting the wall portion between the upstream and downstreamends thereof. The control device controls the first, second and thirdconstriction elements to constrict and release the wall portionindependently of one another. More specifically, the control devicecontrols the first or second constriction element to constrict the wallportion at the upstream or downstream end thereof to close the foodpassageway, and controls the third constriction element to constrict thewall portion between the upstream and downstream ends thereof, wherebyfood contained in the wall portion between the upstream and downstreamends thereof is moved downstream or upstream in the food passageway.Optionally, the control device controls the stimulation device tostimulate the wall portion between the upstream and downstream endsthereof, when the third constriction element constricts the wallportion.

-   -   6a) In accordance with a first alternative, the control device        controls the first constriction element to constrict the wall        portion at the upstream end thereof to restrict the food flow in        the food passageway and controls the stimulation device to        stimulate the constricted wall portion at the upstream end to        close the food passageway. With the food passageway closed at        the upstream end of the constricted wall portion, the control        device controls the third constriction element to constrict the        wall portion between the upstream and downstream ends thereof,        and optionally controls the stimulation device to simultaneously        stimulate the wall portion as the latter is constricted by the        third constriction element. As a result, the food contained in        the wall portion between the upstream and downstream ends        thereof is moved downstream in the food passageway.    -   6b) In accordance with a second alternative, the control device        controls the second constriction element to constrict the wall        portion at the downstream end thereof to restrict the food flow        in the food passageway and controls the stimulation device to        stimulate the constricted wall portion at the downstream end to        close the food passageway. With the food passageway closed at        the downstream end of the constricted wall portion, the control        device controls the third constriction element to constrict the        wall portion between the upstream and downstream ends thereof,        and optionally controls the stimulation device to simultaneously        stimulate the wall portion as the latter is constricted by the        third constriction element. As a result, the food contained in        the wall portion between the upstream and downstream ends        thereof is moved upstream in the food passageway.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion of the smaller compartment withelectric pulses.

The various solutions described above under the headline: “Flowrestriction” to stop the food flow in the food passageway of the stomachmay also be used in any of the above noted embodiments (1a), (1b), (4a),(5), (6), (6a) and (6b).

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of thestomach, such that at least two of the areas are stimulated at differentpoints of time that is, the stimulation is shifted from one area toanother area over time. In addition, the control device controls thestimulation device, such that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before the stimulation device stimulates the areaagain. Furthermore, the control device controls the stimulation deviceto stimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the stomach to achieve the desired flow control,while essentially maintaining over time the natural physical propertiesof the stomach without risking injuring the stomach.

Also, by physically changing the places of stimulation on the stomachover time as described above it is possible to create an advantageouschanging stimulation pattern on the stomach, in order to achieve adesired flow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall during the stimulation thereof, the controldevice may control the stimulation device to, preferably cyclically,vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with the second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue wall portion of the patient'sstomach, preferably with electric pulses. This embodiment isparticularly suited for applications in which the wall portion includesmuscle fibers that react to electrical stimula. In this embodiment, thecontrol device controls the stimulation device to stimulate the wallportion with electric pulses preferably in the form of electric pulsetrains, when the wall portion is in the constricted state, to causecontraction of the wall portion. Of course, the configuration of theelectric pulse trains may be similar to the above described pulse trainsand the control device may control the stimulation device toelectrically stimulate the different areas of the wall of the stomach inthe same manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the stomach, such that the elongate pattern ofelectrical elements extends lengthwise along the wall of the stomach,and the elements abut the respective areas of the wall portion. Theelongate pattern of electrical elements may include one or more rows ofelectrical elements extending lengthwise along the wall of the stomach.Each row of electrical elements may form a straight, helical or zig-zagpath of electrical elements, or any form of path. The control device maycontrol the stimulation device to successively energize the electricalelements longitudinally along the elongate pattern of electricalelements in a direction opposite to, or in the same direction as thatof, the flow in the patient's food passageway.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the foodpassageway is to be kept closed for a relatively long time, the controldevice may control the stimulation device to energize the electricalelements, such that energized electrical elements form two waves ofenergized electrical elements that simultaneously advance from thecenter of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements. Suchwaves of energized electrical elements can be repeated over and overagain without harming the stomach and without moving fluid or gas in anydirection in the food passageway of the stomach.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's stomach. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's stomach, preferably substantially transverse tothe flow direction in the food passageway of the stomach. In a thirdalternative, the elements of the group of energized electrical elementsmay form more than two paths of energized electrical elements extendingon different sides of the patient's stomach, preferably substantiallytransverse to the food flow direction in the patient's food passageway.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's stomach inthe food flow direction in the patient's food passageway. The electricalelements of each group of electrical elements may form a path ofelements extending at least in part around the patient's stomach. In afirst alternative, the electrical elements of each group of electricalelements may form more than two paths of elements extending on differentsides of the patient's stomach, preferably substantially transverse tothe food flow direction in the patient's food passageway. The controldevice may control the stimulation device to energize the groups ofelectrical elements in the series of groups in random, or in accordancewith a predetermined pattern. Alternatively, the control device maycontrol the stimulation device to successively energize the groups ofelectrical elements in the series of groups in a direction opposite to,or in the same direction as that of, the food flow in the patient's foodpassageway, or in both the directions starting from a positionsubstantially at the center of the constricted wall portion. Forexample, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's stomach such that theelongate pattern of electrical elements extends along the stomach in thesame direction as that of the food flow in the patient's food passagewayand the elements abut the respective areas of the wall portion of thestomach.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the stomach. Thus, the control device maycontrol the stimulation device to cool the wall portion, when the wallportion is constricted, to cause contraction of the wall portion. Forexample, the constriction device may constrict the wall portion to atleast restrict the food flow in the food passageway, and the controldevice may control the stimulation device to cool the constricted wallportion to cause contraction thereof, such that the food flow in thefood passageway is at least further restricted, or further restrictedbut not stopped, or stopped. Alternatively, the control device maycontrol the stimulation device to heat the wall portion, when the wallportion is constricted and contracted, to cause expansion of the wallportion. Where applicable, thermal stimulation may be practised in anyof the embodiments of the present invention, and the thermal stimulationmay be controlled in response to various sensors, for example strain,motion or pressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing stomach motion, i.e.natural contractions, such as stomach contractions, pressure sensors forsensing pressure in the stomach, strain sensors for sensing strain ofthe stomach, flow sensors for sensing food flow in the food passagewayof the stomach, spectro-photometrical sensors, Ph-sensors for sensingacidity or alkalinity of the food in the food passageway of the stomach,oxygen-sensors for sensing the oxygen content of the food in the foodpassageway of the stomach, or sensors for sensing the distribution ofthe stimulation on the stimulated stomach. Any conceivable sensors forsensing any other kind of useful physical parameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the food passageway of the patient's stomach, wherein the controldevice controls the constriction device and/or stimulation device tochange the constriction of the patient's wall portion in response to thepressure sensor sensing a predetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's wall portion to increase or decrease the influence on the foodflow in the food passageway during different time periods of the day. Incase a sensor of any of the above-described types for sensing a physicalor functional parameter is provided, either the clock mechanism is usedfor controlling the constriction device and/or stimulation deviceprovided that the parameter sensed by the sensor does not override theclock mechanism, or the sensor is used for controlling the constrictiondevice and/or stimulation device provided that the clock mechanism doesnot override the sensor. Suitably, the control device produces anindication, such as a sound signal or displayed information, in responseto signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's tissue wall portion, and the constrictionand stimulation devices form a constriction/stimulation unit.Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of the tissue wall portion of apatient's stomach, and the stimulation device of the unit comprises aplurality of stimulation elements provided on and distributed along thecontact surfaces. When the control device controls the stimulationdevice to stimulate the wall portion, the stimulation elements stimulatedifferent areas of the wall portion along the length of the wallportion. The stimulation elements preferably comprise electric elements,as described above, for stimulating the wall portion with electricpulses. However, in most applications of the present invention, otherkinds of stimulations, such as thermal stimulation, could be suitable toemploy.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the stomach, and the operation deviceoperates the clamping elements to clamp the wall portion between theclamping elements to constrict the wall portion of the stomach.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the stomach, and the operation device operates the clampingelement to clamp the wall portion between the clamping element and thebone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of thestomach, and the operation device rotates the engagement elements, suchthat the engagement elements engage and constrict the wall portion ofthe stomach.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the stomach, and the operation device moves the clamping elementstowards each other to clamp the wall portion of the stomach between theclamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around thestomach, wherein the loop defines a constriction opening. The operationdevice operates the constriction member in the loop to change the sizeof the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

7) The constriction device is adapted to bend the wall portion of thestomach to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict the length of the tissuewall portion of the patient's stomach. For this purpose, theconstriction device may include two or more of the describedconstriction elements/members to be applied in a row along the length ofthe wall portion, wherein the row extends in the direction of food flowin the food passageway. Preferably, such constriction elements/membersare non-inflatable and mechanically operable or adjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the food passageway assumes a size in theconstricted state that enables the stimulation device to contract thewall portion such that the food flow in the food passageway is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the tissuewall portion of the patient's stomach, so that the patient's wallportion is constricted upon expansion of the cavity and released uponcontraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

-   -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members is        operable by magnetic means, hydraulic means, or electric control        means.

2b) The apparatus comprises a fluid conduit between the pump and thecavity, wherein the reservoir forms part of the conduit. The conduit andpump are devoid of any non-return valve. The reservoir forms a fluidchamber with a variable volume, and the pump distributes fluid from thechamber to the cavity by a reduction in the volume of the chamber andwithdraws fluid from the cavity by an expansion of the volume of thechamber. The apparatus further comprises a motor for driving the pump,wherein the pump comprises a movable wall of the reservoir for changingthe volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of thestomach. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth, and the hydraulic means may also includea pump and an implantable reservoir containing hydraulic fluid. The pumpdistributes hydraulic fluid from the reservoir to the chambers to movethe clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling food flow in the food passageway formed by thetissue wall of a patient's stomach, wherein the apparatus comprises animplantable constriction device for gently constricting a portion of thetissue wall to influence the food flow in the food passageway, astimulation device for intermittently and individually stimulatingdifferent areas of the wall portion, as the constriction deviceconstricts the wall portion, to cause contraction of the wall portion tofurther influence the food flow in the food passageway, wherein theconstriction and stimulation devices form an operableconstriction/stimulation unit, a source of energy, and a control deviceoperable from outside the patient's body to control the source of energyto release energy for use in connection with the operation of theconstriction/stimulation unit. In a simple form of the invention, thesource of energy, such as a battery or accumulator, is implantable inthe patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction/stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

The present invention also provides a method for using an apparatus asdescribed above comprising

-   -   implanting the constriction and stimulation devices of the        apparatus on the stomach of an obese patient surgically modified        by any one of a group of operations called Vertical Banded        Gastroplasty,    -   providing a wireless remote control for controlling the        constriction device and/or stimulation device from outside the        patient's body, and    -   operating the wireless remote control to control the        constriction device and/or stimulation device.

Male Sexual Dysfunction

Another object of the present invention is to provide an apparatus fortreating a male impotent patient.

In accordance with this object of the present invention, there isprovided an apparatus for treating a male impotent patient comprising astimulation device for stimulating at least one penile portion of thepatient's normal penile tissue or the prolongation thereof, and

a control device for controlling the stimulation device to stimulate thepenile portion to cause contraction thereof to at least restrict theblood flow leaving the penis to achieve erection. In the following theterm “penile portion” is to be understood as: the penile portion of thepatient's normal penile tissue or the prolongation thereof.

In accordance with a main embodiment of the present invention, theapparatus further comprises an implantable constriction device forgently constricting the penile portion to restrict the blood flowleaving the penis, wherein the control device controls the stimulationdevice to stimulate the penile portion to at least further restrict theblood flow leaving the penis to achieve erection.

The present invention provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stagerestriction of the exit penile blood flow. Thus, the constriction devicemay gently constrict the penile portion by applying a relatively weakforce against the penile portion, and the stimulation device maystimulate the constricted penile portion to achieve the desired finalrestriction of the exit penile blood flow. The phrase “gentlyconstricting” is to be understood as constricting the penile portionwithout risking injuring the tissue of the penile portion.

Preferably, the stimulation device is adapted to stimulate differentareas of the penile portion as the constriction device constricts thepenile portion, and the control device controls the stimulation deviceto intermittently and individually stimulate the areas of the penileportion. This intermittent and individual stimulation of different areasof the penile portion allows tissue of the penile portion to maintainsubstantially normal blood circulation during the operation of theapparatus of the invention.

In a preferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the penileportion as desired, wherein the control device controls the constrictiondevice to adjust the constriction of the penile portion. The controldevice may control the constriction and stimulation devicesindependently of each other, and simultaneously. Optionally, the controldevice may control the stimulation device to stimulate, or to notstimulate the penile portion while the control device controls theconstriction device to change the constriction of the penile portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the penileportion, while controlling the constriction device to adjust theconstriction of the penile portion until the desired restriction of theexit penile blood flow is obtained, i.e., to achieve erection.

Flow Restriction

In a principal embodiment of the invention, the constriction device isadapted to constrict the penile portion to at least restrict the exitpenile blood flow, and the control device controls the stimulationdevice to cause contraction of the constricted penile portion, so thatthe exit penile blood flow is at least further restricted. Specifically,the constriction device is adapted to constrict the penile portion to aconstricted state in which the blood circulation in the constrictedpenile portion is substantially unrestricted and the exit penile bloodflow is at least restricted, and the control device controls thestimulation device to cause contraction of the penile portion, so thatthe exit penile blood flow is at least further restricted when thepenile portion is kept by the constriction device in the constrictedstate.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the penile portion, such that exit penile blood flow isrestricted but not stopped, and controls the stimulation device tostimulate the constricted penile portion to cause contraction thereof,such that exit penile blood flow is further restricted but not stopped.More precisely, the control device may control the stimulation device ina first mode to stimulate the constricted penile portion to furtherrestrict but not stop the exit penile blood flow and to:

a) control the stimulation device in a second mode to cease thestimulation of the penile portion to increase the exit penile bloodflow; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the penile portion and release the penileportion to restore the exit penile blood flow.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the penile portion, suchthat exit penile blood flow is restricted but not stopped, and controlsthe stimulation device to stimulate the constricted penile portion tocause contraction thereof, such that exit penile blood flow is stopped.More precisely, the control device may control the stimulation device ina first mode to stimulate the constricted penile portion to furtherrestrict but not stop the exit penile blood flow and to:

a) control the stimulation device in a second mode to cease thestimulation of the penile portion to allow exit penile blood flow; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the penile portion and release the penileportion to restore the exit penile blood flow.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the penile portion, suchthat the exit penile blood flow is substantially stopped, and controlsthe stimulation device to stimulate the constricted penile portion tocause contraction thereof, such that the exit penile blood flow iscompletely stopped. More precisely, the control device may control thestimulation device in a first mode to stimulate the constricted penileportion to completely stop the exit penile blood flow and to:

a) control the stimulation device in a second mode to cease thestimulation of the penile portion to allow exit penile blood flow; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the penile portion and release the penileportion to restore the exit penile blood flow.

Where the stimulation device stimulates the constricted penile portionto contract, such that the exit penile blood flow is stopped, thecontrol device suitably controls the stimulation device tosimultaneously and cyclically stimulate a first length of theconstricted penile portion and a second length of the constricted penileportion, which is located downstream of the first length, wherein thecontrol device controls the stimulation device to progressivelystimulate the first length in the upstream direction of the exit penileblood flow and to progressively stimulate the second length in thedownstream direction of the exit penile blood flow.

The control device may control the stimulation device to change thestimulation of the penile portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the penile portion inresponse to a sensed pressure increase, such that the exit penile bloodflow remains stopped. Any sensor for sensing a physical parameter of thepatient, such as a pressure in the patient's body that relates to thepressure on the penile portion may be provided, wherein the controldevice controls the stimulation device in response to signals from thesensor. Such a sensor may for example sense the pressure in thepatient's abdomen, the pressure against the implanted constrictiondevice or the pressure on the penile portion.

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the penile portion, suchthat the exit penile blood flow Is stopped. More precisely, the controldevice may control the constriction device in a first mode to constrictthe constricted penile portion to stop the exit penile blood flow and ina second mode to cease the constriction of the penile portion to restoreexit penile blood flow. In this case, the control device only controlsthe stimulation device to stimulate the penile portion when needed. Asensor for sensing a physical parameter of the patient's body thatrelates to the pressure may be provided, wherein the control devicecontrols the stimulation device in response to signals from the sensor.Such a physical parameter may be a pressure in the patients abdomen andthe sensor may be a pressure sensor.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the patient's penile portion in theconstricted state. In this case, the control device may be convenientlyused by the patien, to control the stimulation device to stimulate theconstricted tissue penile portion, preferably while adjusting thestimulation intensity, to cause contraction of the penile portion, suchthat the exit penile blood flow is at least further restricted orstopped, to achieve erection, and, when desired, to control thestimulation device to cease the stimulation. More precisely, the controldevice may:

a) control the stimulation device in a first mode to stimulate theconstricted penile portion to further restrict the exit penile bloodflow, and control the stimulation device in a second mode to cease thestimulation of the penile portion to increase the exit penile bloodflow; or

b) control the stimulation device in a first mode to stimulate theconstricted penile portion to stop the exit penile blood flow, andcontrol the stimulation device in a second mode to cease the stimulationof the penile portion to allow exit penile blood flow.

The first mode may be temporary until erection has been achieved.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any penile portions of a series of penileportions of the patient. The control device may control the constrictiondevice to activate the constriction elements in random or in accordancewith a predetermined sequence. In this case, the stimulation deviceincludes stimulation elements positioned on the constriction elements,wherein the control device controls the stimulation device to activatethe stimulation elements to stimulate any penile portions of the seriesof penile portions constricted by the constriction elements to close theexit penile blood vessels.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the penileportions of the series of penile portions, and controls the stimulationdevice to activate the stimulation elements to stimulate any constrictedpenile portions in random or in accordance with a predetermined sequenceto close the exit penile blood vessels. The design of the constrictiondevice in the form of a plurality of separate constriction elementsmakes possible to counteract growth of hard fibrosis where theconstriction device is implanted.

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the penile portion, suchthat at least two of the areas are stimulated at different points oftime that is, the stimulation is shifted from one area to another areaover time. In addition, the control device controls the stimulationdevice, such that an area of the different areas that currently is notstimulated has time to restore substantially normal blood circulationbefore the stimulation device stimulates the area again. Furthermore,the control device controls the stimulation device to stimulate eacharea during successive time periods, wherein each time period is shortenough to maintain satisfactory blood circulation in the area until thelapse of the time period. This gives the advantage that the apparatus ofthe present invention enables continuous stimulation of the penileportion to achieve the desired exit penile blood flow control, whileessentially maintaining over time the natural physical properties of thepenile portion without risking injuring the penile portion.

Also, by physically changing the places of stimulation on the penileportion over time as described above it is possible to create anadvantageous changing stimulation pattern on the penile portion, inorder to achieve a desired flow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the penile portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the penile portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall during the stimulation thereof, the controldevice may control the stimulation device to, preferably cyclically,vary the intensity of the stimulation of the penile portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of thepenile portion with pulses that preferably form pulse trains. At least afirst area and a second area of the areas of the penile portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with the second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the penile portion, it is also possible to control each off timeperiod between pulse trains to last long enough to restore substantiallynormal blood circulation in the area when the latter is not stimulatedduring the off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue penile portion, preferably withelectric pulses. This embodiment is particularly suited for applicationsin which the penile portion includes muscle fibers that react toelectrical stimula. In this embodiment, the control device controls thestimulation device to stimulate the penile portion with electric pulsespreferably in the form of electric pulse trains, when the penile portionis in the constricted state, to cause contraction of the penile portion.Of course, the configuration of the electric pulse trains may be similarto the above described pulse trains and the control device may controlthe stimulation device to electrically stimulate the different areas ofthe penile portion in the same manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the penile portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's penile portion, such that the elongate pattern ofelectrical elements extends lengthwise along the penile portion, and theelements abut the respective areas of the penile portion. The elongatepattern of electrical elements may include one or more rows ofelectrical elements extending lengthwise along the penile portion. Eachrow of electrical elements may form a straight, helical or zig-zag pathof electrical elements, or any form of path. The control device maycontrol the stimulation device to successively energize the electricalelements longitudinally along the elongate pattern of electricalelements in a direction opposite to, or in the same direction as thatof, the blood flow.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted penile portion towardsboth ends of the elongate pattern of electrical elements. The controldevice may control the stimulation device to energize the electricalelements, such that energized electrical elements form two waves ofenergized electrical elements that simultaneously advance from thecenter of the constricted penile portion in two opposite directionstowards both ends of the elongate pattern of electrical elements. Suchwaves of energized electrical elements can be repeated over and overagain without harming the penile portion.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's penile portion. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's penile portion, preferably substantiallytransverse to the flow direction. In a third alternative, the elementsof the group of energized electrical elements may form more than twopaths of energized electrical elements extending on different sides ofthe patient's penile portion, preferably substantially transverse to theexit blood flow direction.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's penileportion in the flow direction. The electrical elements of each group ofelectrical elements may form a path of elements extending at least inpart around the patient's penile portion. In a first alternative, theelectrical elements of each group of electrical elements may form morethan two paths of elements extending on different sides of the patient'spenile portion, preferably substantially transverse to the flowdirection. The control device may control the stimulation device toenergize the groups of electrical elements in the series of groups inrandom, or in accordance with a predetermined pattern. Alternatively,the control device may control the stimulation device to successivelyenergize the groups of electrical elements in the series of groups in adirection opposite to, or in the same direction as that of, the flow, orin both the directions starting from a position substantially at thecenter of the constricted penile portion. For example, groups ofenergized electrical elements may form advancing waves of energizedelectrical elements, as described above; that is, the control device maycontrol the stimulation device to energize the groups of electricalelements, such that energized electrical elements form two waves ofenergized electrical elements that simultaneously advance from thecenter of the constricted penile portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's penile portion such thatthe elongate pattern of electrical elements extends along the penileportion in the same direction as that of the flow and the elements abutthe respective areas of the penile portion.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the penile portion. Thus, the control device may control thestimulation device to cool the penile portion, when the penile portionis constricted, to cause contraction of the penile portion. For example,the constriction device may constrict the penile portion to at leastrestrict the flow, and the control device may control the stimulationdevice to cool the constricted penile portion to cause contractionthereof, such that the flow is at least further restricted, or furtherrestricted but not stopped, or stopped. Alternatively, the controldevice may control the stimulation device to heat the penile portion,when the penile portion is constricted and contracted, to causeexpansion of the penile portion. Where applicable, thermal stimulationmay be practised in any of the embodiments of the present invention, andthe thermal stimulation may be controlled in response to varioussensors, for example strain, motion or pressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing motion, i.e. naturalcontractions, pressure sensors for sensing pressure, strain sensors forsensing strain of the penile portion, flow sensors for sensing bloodflow, spectro-photometrical sensors, or sensors for sensing thedistribution of the stimulation on the stimulated penile portion. Anyconceivable sensors for sensing any other kind of useful physicalparameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressureon the penile portion, wherein the control device controls theconstriction device and/or stimulation device to change the constrictionof the patient's penile portion in response to the pressure sensorsensing a predetermined value of measured pressure.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's penileportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's penile portion to increase or decrease the restriction of theexit penile blood flow during different time periods of the day. In casea sensor of any of the above-described types for sensing a physical orfunctional parameter is provided, either the clock mechanism is used forcontrolling the constriction device and/or stimulation device providedthat the parameter sensed by the sensor does not override the clockmechanism, or the sensor is used for controlling the constriction deviceand/or stimulation device provided that the dock mechanism does notoverride the sensor. Suitably, the control device produces anindication, such as a sound signal or displayed information, in responseto signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's penile portion, and the constriction andstimulation devices form a constriction/stimulation unit. Preferably,the constriction and stimulation devices of the constriction/stimulationunit are integrated in a single piece suitable for implantation. Theconstriction device of the unit comprises contact surfaces dimensionedto contact a length of the penile portion, and the stimulation device ofthe unit comprises a plurality of stimulation elements provided on anddistributed along the contact surfaces. When the control device controlsthe stimulation device to stimulate the penile portion, the stimulationelements stimulate different areas of the penile portion along thelength of the penile portion. The stimulation elements preferablycomprise electric elements, as described above, for stimulating thepenile portion with electric pulses. However, in most of the embodimentsof the present invention, other kinds of stimulations could be suitableto employ.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the penileportion on different sides of the penile portion, and the operationdevice operates the clamping elements to clamp the penile portionbetween the clamping elements to constrict the penile portion.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the penile portion onone side thereof, and the operation device operates the clamping elementto clamp the penile portion between the clamping element and the bone ortissue of the patient to constrict the penile portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of thepenile portion, and the operation device rotates the engagementelements, such that the engagement elements engage and constrict thepenile portion.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the penile portion, and the operation device moves the clampingelements towards each other to clamp the penile portion between theclamping elements, to constrict the penile portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around thepenile portion, wherein the loop defines a constriction opening. Theoperation device operates the constriction member in the loop to changethe size of the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

7) The constriction device is adapted to bend the penile portion toconstrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict the length of the penileportion. For this purpose, the constriction device may include two ormore of the described constriction elements/members to be applied in arow along the length of the penile portion, wherein the row extends inthe direction of the exit penile blood flow. Preferably, suchconstriction elements/members are non-inflatable and mechanicallyoperable or adjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many embodiments of the present invention, theoperation device suitably operates the constriction device, such thatthe penile portion assumes a constriction in the constricted state thatenables the stimulation device to contract the penile portion such thatthe exit penile blood flow is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the penileportion, so that the penile portion is constricted upon expansion of thecavity and released upon contraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the penile portion, so that thepenile portion is constricted upon contraction of the bellows andreleased upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the penile portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

-   -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members is        operable by magnetic means, hydraulic means, or electric control        means.

2b) The apparatus comprises a fluid conduit between the pump and thecavity, wherein the reservoir forms part of the conduit. The conduit andpump are devoid of any non-return valve. The reservoir forms a fluidchamber with a variable volume, and the pump distributes fluid from thechamber to the cavity by a reduction in the volume of the chamber andwithdraws fluid from the cavity by an expansion of the volume of thechamber. The apparatus further comprises a motor for driving the pump,wherein the pump comprises a movable wall of the reservoir for changingthe volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's penile portion upon expansionor contraction of the first reservoir. By changing the volume of thesecond reservoir hydraulic fluid is distributed between the tworeservoirs, so that the first reservoir is either expanded orcontracted. This embodiment requires no non-return valve in the fluidcommunication conduits between the two reservoirs, which is beneficialto long-term operation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's penileportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of thepatient's penile portion. The hydraulic means, which may include thereverse servo described above, hydraulically moves the elongatedclamping elements towards the penile portion to constrict the penileportion. For example, the constriction device may have hydraulicchambers in which the clamping elements slide back and forth and thehydraulic means may also include a pump and an implantable reservoircontaining hydraulic fluid. The pump distributes hydraulic fluid fromthe reservoir to the chambers to move the clamping elements against thepenile portion, and distributes hydraulic fluid from the chambers to thereservoir to move the clamping elements away from the penile portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thepenile portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for treating a male impotent patient, wherein the apparatuscomprises an implantable constriction device for gently constricting atleast one penile portion of the patient's normal penile tissue or theprolongation thereof to restrict the exit penile blood flow, astimulation device for stimulating the penile portion, as theconstriction device constricts the penile portion, to cause contractionof the penile portion to further restrict the exit penile blood flow toachieve erection, wherein the constriction and stimulation devices forman operable constriction/stimulation unit, a source of energy, and acontrol device operable from outside the patient's body to control thesource of energy to release energy for use in connection with theoperation of the constriction/stimulation unit.

In a simple form of the invention, the source of energy, such as abattery or accumulator, is implantable in the patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influence by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

The present invention also provides a method for using an apparatus asdescribed above to treat a male impotent patient, comprising providing awireless remote control adapted to control the constriction deviceand/or stimulation device from outside the patient's body, and operatingthe wireless remote control by the patient, when the patient wants toachieve erection.

Female Sexual Dysfunction

Another object of the present invention is to provide an apparatus fortreating female sexual dysfunction which obviates at least some of thedisadvantages in the prior art and which positively affects sexualstimuli and orgasm.

In accordance with this object of the present invention, there isprovided an apparatus for treating sexual dysfunction of a femalepatient comprising an implantable stimulation device for stimulating atleast one portion of the patient's female erectile tissue, and

a control device for controlling the stimulation device to stimulate theerectile tissue portion to cause contraction thereof to at leastrestrict the venous blood flow leaving the erectile tissue to obtainengorgement with blood of the female erectile tissue.In the following the term “erectile tissue portion” is to be understoodas: 1) tissue of the female sexual organs that before or during sexualintercourse are filled with blood including, but not limited to, thecorpora cavernosa of the clitoris and the vestibular bulbs. 2)extensions of said tissue, including but not limited to blood vesselsand the surrounding tissues.

In accordance with a main embodiment of the present invention, theapparatus further comprises an implantable constriction device forgently constricting the erectile tissue portion to restrict the venousblood flow leaving the erectile tissue, wherein the control devicecontrols the stimulation device to stimulate the erectile tissue portionconstricted by the constriction device to at least further restrict thevenous blood flow leaving the erectile tissue to obtain engorgement withblood of the female erectile tissue.

The present invention provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stagerestriction of the exit erectile blood flow. Thus, the constrictiondevice may gently constrict the erectile tissue portion by applying arelatively weak force against the erectile tissue portion, and thestimulation device may stimulate the constricted erectile tissue portionto achieve the desired final restriction of the exit erectile bloodflow. The phrase “gently constricting” is to be understood asconstricting the erectile tissue portion without risking injuring theerectile tissue portion.

Preferably, the stimulation device is adapted to stimulate differentareas of the erectile tissue portion as the constriction deviceconstricts the erectile tissue portion, and the control device controlsthe stimulation device to intermittently and individually stimulate theareas of the erectile tissue portion. This intermittent and individualstimulation of different areas of the erectile tissue portion allowstissue of the erectile tissue portion to maintain substantially normalblood circulation during the operation of the apparatus of theinvention.

In a preferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the erectiletissue portion as desired, wherein the control device controls theconstriction device to adjust the constriction of the erectile tissueportion. The control device may control the constriction and stimulationdevices independently of each other, and simultaneously. Optionally, thecontrol device may control the stimulation device to stimulate, or tonot stimulate the erectile tissue portion while the control devicecontrols the constriction device to change the constriction of theerectile tissue portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate theerectile tissue portion, while controlling the constriction device toadjust the constriction of the erectile tissue portion until the desiredrestriction of the exit erectile blood flow is obtained, i.e., to obtainengorgement with blood of the female erectile tissue.

Flow Restriction

In a principal embodiment of the invention, the constriction device isadapted to constrict the erectile tissue portion to at least restrictthe exit erectile blood flow, and the control device controls thestimulation device to cause contraction of the constricted erectiletissue portion, so that the exit erectile blood flow is at least furtherrestricted. Specifically, the constriction device is adapted toconstrict the erectile tissue portion to a constricted state in whichthe blood circulation in the constricted erectile tissue portion issubstantially unrestricted and the exit erectile blood flow is at leastrestricted, and the control device controls the stimulation device tocause contraction of the erectile tissue portion, so that the exiterectile blood flow is at least further restricted when the erectiletissue portion is kept by the constriction device in the constrictedstate.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the erectile tissue portion, such that exit erectile bloodflow is restricted but not stopped, and controls the stimulation deviceto stimulate the constricted erectile tissue portion to causecontraction thereof, such that exit erectile blood flow is furtherrestricted but not stopped. More precisely, the control device maycontrol the stimulation device in a first mode to stimulate theconstricted erectile tissue portion to further restrict but not stop theexit erectile blood flow and to:

a) control the stimulation device in a second mode to cease thestimulation of the erectile tissue portion to increase the exit erectileblood flow; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the erectile tissue portion and release theerectile tissue portion to restore the exit erectile blood flow.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the erectile tissueportion, such that exit erectile blood flow is restricted but notstopped, and controls the stimulation device to stimulate theconstricted erectile tissue portion to cause contraction thereof, suchthat exit erectile blood flow is stopped. More precisely, the controldevice may control the stimulation device in a first mode to stimulatethe constricted erectile tissue portion to further restrict but not stopthe exit erectile blood flow and to:

a) control the stimulation device in a second mode to cease thestimulation of the erectile tissue portion to allow exit erectile bloodflow; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the erectile tissue portion and release theerectile tissue portion to restore the exit erectile blood flow.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the erectile tissueportion, such that the exit erectile blood flow is substantiallystopped, and controls the stimulation device to stimulate theconstricted erectile tissue portion to cause contraction thereof, suchthat the exit erectile blood flow is completely stopped. More precisely,the control device may control the stimulation device in a first mode tostimulate the constricted erectile tissue portion to completely stop theexit erectile blood flow and to:

a) control the stimulation device in a second mode to cease thestimulation of the erectile tissue portion to allow exit erectile bloodflow; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the erectile tissue portion and release theerectile tissue portion to restore the exit erectile blood flow.

Where the stimulation device stimulates the constricted erectile tissueportion to contract, such that the exit erectile blood flow is stopped,the control device suitably controls the stimulation device tosimultaneously and cyclically stimulate a first length of theconstricted erectile tissue portion and a second length of theconstricted erectile tissue portion, which is located downstream of thefirst length, wherein the control device controls the stimulation deviceto progressively stimulate the first length in the upstream direction ofthe exit erectile blood flow and to progressively stimulate the secondlength in the downstream direction of the exit erectile blood flow.

The control device may control the stimulation device to change thestimulation of the erectile tissue portion in response to a sensedphysical parameter of the patient or functional parameter of theapparatus. For example, the control device may control the stimulationdevice to increase the intensity of the stimulation of the erectiletissue portion in response to a sensed pressure increase, such that theexit erectile blood flow remains stopped. Any sensor for sensing aphysical parameter of the patient, such as a pressure in the patient'sbody that relates to the pressure on the erectile tissue portion may beprovided, wherein the control device controls the stimulation device inresponse to signals from the sensor. Such a sensor may for example sensethe pressure in the patient's abdomen, the pressure against theimplanted constriction device or the pressure on the erectile tissueportion.

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the erectile tissueportion, such that the exit erectile blood flow is stopped. Moreprecisely, the control device may control the constriction device in afirst mode to constrict the constricted erectile tissue portion to stopthe exit erectile blood flow and in a second mode to cease theconstriction of the erectile tissue portion to restore exit erectileblood flow. In this case, the control device only controls thestimulation device to stimulate the erectile tissue portion when needed.A sensor for sensing a physical parameter of the patient's body thatrelates to the pressure may be provided, wherein the control devicecontrols the stimulation device in response to signals from the sensor.Such a physical parameter may be a pressure in the patient's abdomen andthe sensor may be a pressure sensor.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the patient's erectile tissue portionin the constricted state. In this case, the control device may beconveniently used by the patien, to control the stimulation device tostimulate the constricted tissue erectile tissue portion, preferablywhile adjusting the stimulation intensity, to cause contraction of theerectile tissue portion, such that the exit erectile blood flow is atleast further restricted or stopped, to achieve erection, and, whendesired, to control the stimulation device to cease the stimulation.More precisely, the control device may:

a) control the stimulation device in a first mode to stimulate theconstricted erectile tissue portion to further restrict the exiterectile blood flow, and control the stimulation device in a second modeto cease the stimulation of the erectile tissue portion to increase theexit erectile blood flow; or

b) control the stimulation device in a first mode to stimulate theconstricted erectile tissue portion to stop the exit erectile bloodflow, and control the stimulation device in a second mode to cease thestimulation of the erectile tissue portion to allow exit erectile bloodflow.

The first mode may be temporary until erection has been achieved.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any erectile tissue portions of a seriesof erectile tissue portions of the patient. The control device maycontrol the constriction device to activate the constriction elements inrandom or in accordance with a predetermined sequence. In this case, thestimulation device includes stimulation elements positioned on theconstriction elements, wherein the control device controls thestimulation device to activate the stimulation elements to stimulate anyerectile tissue portions of the series of erectile tissue portionsconstricted by the constriction elements to close the exit erectileblood vessels.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the erectiletissue portions of the series of erectile tissue portions, and controlsthe stimulation device to activate the stimulation elements to stimulateany constricted erectile tissue portions in random or in accordance witha predetermined sequence to close the exit erectile blood vessels. Thedesign of the constriction device in the form of a plurality of separateconstriction elements makes possible to counteract growth of hardfibrosis where the constriction device is implanted.

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the erectile tissue portion,such that at least two of the areas are stimulated at different pointsof time that is, the stimulation is shifted from one area to anotherarea over time. In addition, the control device controls the stimulationdevice, such that an area of the different areas that currently is notstimulated has time to restore substantially normal blood circulationbefore the stimulation device stimulates the area again. Furthermore,the control device controls the stimulation device to stimulate eacharea during successive time periods, wherein each time period is shortenough to maintain satisfactory blood circulation in the area until thelapse of the time period. This gives the advantage that the apparatus ofthe present invention enables continuous stimulation of the erectiletissue portion to achieve the desired exit erectile blood flow control,while essentially maintaining over time the natural physical propertiesof the erectile tissue portion without risking injuring the erectiletissue portion.

Also, by physically changing the places of stimulation on the erectiletissue portion over time as described above it is possible to create anadvantageous changing stimulation pattern on the erectile tissueportion, in order to achieve a desired flow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the erectile tissue portion at a time, forexample by sequentially stimulating the different areas. Furthermore,the control device may control the stimulation device to cyclicallypropagate the stimulation of the areas along the erectile tissueportion, preferably in accordance with a determined stimulation pattern.To achieve the desired reaction of the tissue wall during thestimulation thereof, the control device may control the stimulationdevice to, preferably cyclically, vary the intensity of the stimulationof the erectile tissue portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of theerectile tissue portion with pulses that preferably form pulse trains.At least a first area and a second area of the areas of the erectiletissue portion may be repeatedly stimulated with a first pulse train anda second pulse train, respectively, such that the first and second pulsetrains over time are shifted relative to each other. For example, thefirst area may be stimulated with the first pulse train, while thesecond area is not stimulated with the second pulse train, and viceversa. Alternatively, the first and second pulse trains may be shiftedrelative to each other, such that the first and second pulse trains atleast partially overlap each other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the erectile tissue portion, it is also possible to control each offtime period between pulse trains to last long enough to restoresubstantially normal blood circulation in the area when the latter isnot stimulated during the off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue erectile tissue portion, preferablywith electric pulses. This embodiment is particularly suited forapplications in which the erectile tissue portion includes muscle fibersthat react to electrical stimula. In this embodiment, the control devicecontrols the stimulation device to stimulate the erectile tissue portionwith electric pulses preferably in the form of electric pulse trains,when the erectile tissue portion is in the constricted state, to causecontraction of the erectile tissue portion. Of course, the configurationof the electric pulse trains may be similar to the above described pulsetrains and the control device may control the stimulation device toelectrically stimulate the different areas of the erectile tissueportion in the same manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the erectile tissue portion with electricpulses. Optionally, the electrical elements may be placed in a fixedorientation relative to one another. The control device controls theelectric stimulation device to electrically energize the electricalelements, one at a time, or groups of electrical elements at a time.Preferably, the control device controls the electric stimulation deviceto cyclically energize each element with electric pulses. Optionally,the control device may control the stimulation device to energize theelectrical elements, such that the electrical elements are energized oneat a time in sequence, or such that a number or groups of the electricalelements are energized at the same time. Also, groups of electricalelements may be sequentially energized, either randomly or in accordancewith a predetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's erectile tissue portion, such that the elongate pattern ofelectrical elements extends lengthwise along the erectile tissueportion, and the elements abut the respective areas of the erectiletissue portion. The elongate patter of electrical elements may includeone or more rows of electrical elements extending lengthwise along theerectile tissue portion. Each row of electrical elements may form astraight, helical or zig-zag path of electrical elements, or any form ofpath. The control device may control the stimulation device tosuccessively energize the electrical elements longitudinally along theelongate pattern of electrical elements in a direction opposite to, orin the same direction as that of, the venous blood flow.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted erectile tissue portiontowards both ends of the elongate pattern of electrical elements. Thecontrol device may control the stimulation device to energize theelectrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted erectile tissue portion in two oppositedirections towards both ends of the elongate pattern of electricalelements. Such waves of energized electrical elements can be repeatedover and over again without harming the erectile tissue portion.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's erectile tissue portion. Ina second alternative, the elements of the group of energized electricalelements may form two paths of energized electrical elements extendingon mutual sides of the patient's erectile tissue portion, preferablysubstantially transverse to the flow direction. In a third alternative,the elements of the group of energized electrical elements may form morethan two paths of energized electrical elements extending on differentsides of the patient's erectile tissue portion, preferably substantiallytransverse to the exit blood flow direction.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's erectiletissue portion in the flow direction. The electrical elements of eachgroup of electrical elements may form a path of elements extending atleast in part around the patient's erectile tissue portion. In a firstalternative, the electrical elements of each group of electricalelements may form more than two paths of elements extending on differentsides of the patient's erectile tissue portion, preferably substantiallytransverse to the flow direction. The control device may control thestimulation device to energize the groups of electrical elements in theseries of groups in random, or in accordance with a predeterminedpattern. Alternatively, the control device may control the stimulationdevice to successively energize the groups of electrical elements in theseries of groups in a direction opposite to, or in the same direction asthat of the blood flow, or in both directions starting from a positionsubstantially at the center of the constricted erectile tissue portion.For example, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted erectile tissue portion in two oppositedirections towards both ends of the elongate pattern of electricalelements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's erectile tissue portionsuch that the elongate pattern of electrical elements extends along theerectile tissue portion in the same direction as that of the flow andthe elements abut the respective areas of the erectile tissue portion.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the erectile tissue portion. Thus, the control device maycontrol the stimulation device to cool the erectile tissue portion, whenthe erectile tissue portion is constricted, to cause contraction of theerectile tissue portion. For example, the constriction device mayconstrict the erectile tissue portion to at least restrict the flow, andthe control device may control the stimulation device to cool theconstricted erectile tissue portion to cause contraction thereof, suchthat the flow is at least further restricted, or further restricted butnot stopped, or stopped. Alternatively, the control device may controlthe stimulation device to heat the erectile tissue portion, when theerectile tissue portion is constricted and contracted, to causeexpansion of the erectile tissue portion. Where applicable, thermalstimulation may be practised in any of the embodiments of the presentinvention, and the thermal stimulation may be controlled in response tovarious sensors, for example strain, motion or pressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing motion, i.e. naturalcontractions, pressure sensors for sensing pressure, strain sensors forsensing strain of the erectile tissue portion, flow sensors for sensingblood flow, spectro-photometrical sensors, or sensors for sensing thedistribution of the stimulation on the stimulated erectile tissueportion. Any conceivable sensors for sensing any other kind of usefulphysical parameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressureon the erectile tissue portion, wherein the control device controls theconstriction device and/or stimulation device to change the constrictionof the patient's erectile tissue portion in response to the pressuresensor sensing a predetermined value of measured pressure.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's erectiletissue portion in response to the time of day. For that purpose thecontrol device may include a clock mechanism for controlling theconstriction device and/or stimulation device to change the constrictionof the patient's erectile tissue portion to increase or decrease therestriction of the exit erectile blood flow during different timeperiods of the day. In case a sensor of any of the above-described typesfor sensing a physical or functional parameter is provided, either theclock mechanism is used for controlling the constriction device and/orstimulation device provided that the parameter sensed by the sensor doesnot override the clock mechanism, or the sensor is used for controllingthe constriction device and/or stimulation device provided that theclock mechanism does not override the sensor. Suitably, the controldevice produces an indication, such as a sound signal or displayedinformation, in response to signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's erectile tissue portion, and theconstriction and stimulation devices form a constriction/stimulationunit. Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of the erectile tissue portion,and the stimulation device of the unit comprises a plurality ofstimulation elements provided on and distributed along the contactsurfaces. When the control device controls the stimulation device tostimulate the erectile tissue portion, the stimulation elementsstimulate different areas of the erectile tissue portion along thelength of the erectile tissue portion. The stimulation elementspreferably comprise electric elements, as described above, forstimulating the erectile tissue portion with electric pulses. However,in most of the embodiments of the present invention, other kinds ofstimulations could be suitable to employ.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the erectiletissue portion on different sides of the erectile tissue portion, andthe operation device operates the clamping elements to clamp theerectile tissue portion between the clamping elements to constrict theerectile tissue portion.2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the erectile tissueportion on one side thereof, and the operation device operates theclamping element to clamp the erectile tissue portion between theclamping element and the bone or tissue of the patient to constrict theerectile tissue portion.3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of theerectile tissue portion, and the operation device rotates the engagementelements, such that the engagement elements engage and constrict theerectile tissue portion.4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the erectile tissue portion, and the operation device moves theclamping elements towards each other to clamp the erectile tissueportion between the clamping elements, to constrict the erectile tissueportion.5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around theerectile tissue portion, wherein the loop defines a constrictionopening. The operation device operates the constriction member in theloop to change the size of the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.        7) The constriction device is adapted to bend the erectile        tissue portion to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict the length of the erectiletissue portion. For this purpose, the constriction device may includetwo or more of the described constriction elements/members to be appliedin a row along the length of the erectile tissue portion, wherein therow extends in the direction of the exit erectile blood flow.Preferably, such constriction elements/members are non-inflatable andmechanically operable or adjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many embodiments of the present invention, theoperation device suitably operates the constriction device, such thatthe erectile tissue portion assumes a constriction in the constrictedstate that enables the stimulation device to contract the erectiletissue portion such that the exit erectile blood flow is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the erectiletissue portion, so that the erectile tissue portion is constricted uponexpansion of the cavity and released upon contraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the erectile tissue portion, so thatthe erectile tissue portion is constricted upon contraction of thebellows and released upon expansion of the bellows. Thus, a relativelysmall addition of hydraulic fluid to the bellows causes a relativelylarge increase in the constriction of the erectile tissue portion. Sucha bellows may also be replaced by a suitably designed piston/cylindermechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

-   -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members is        operable by magnetic means, hydraulic means, or electric control        means.

2b) The apparatus comprises a fluid conduit between the pump and thecavity, wherein the reservoir forms part of the conduit. The conduit andpump are devoid of any non-return valve. The reservoir forms a fluidchamber with a variable volume, and the pump distributes fluid from thechamber to the cavity by a reduction in the volume of the chamber andwithdraws fluid from the cavity by an expansion of the volume of thechamber. The apparatus further comprises a motor for driving the pump,wherein the pump comprises a movable wall of the reservoir for changingthe volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's erectile portion uponexpansion or contraction of the first reservoir. By changing the volumeof the second reservoir hydraulic fluid is distributed between the tworeservoirs, so that the first reservoir is either expanded orcontracted. This embodiment requires no non-return valve in the fluidcommunication conduits between the two reservoirs, which is beneficialto long-term operation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient'serectile tissue portion upon operation of the first piston/cylindermechanism. By operating the second piston/cylinder mechanism hydraulicfluid is distributed between the two piston/cylinder mechanisms, so thatthe first piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of thepatient's erectile tissue portion. The hydraulic means, which mayinclude the reverse servo described above, hydraulically moves theelongated clamping elements towards the erectile tissue portion toconstrict the erectile tissue portion. For example, the constrictiondevice may have hydraulic chambers in which the clamping elements slideback and forth and the hydraulic means may also include a pump and animplantable reservoir containing hydraulic fluid. The pump distributeshydraulic fluid from the reservoir to the chambers to move the clampingelements against the erectile tissue portion, and distributes hydraulicfluid from the chambers to the reservoir to move the clamping elementsaway from the erectile tissue portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of theerectile tissue portion. The wireless remote control may comprise atleast one external signal transmitter or transceiver and at least oneinternal signal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for treating sexual dysfunction of female patient, wherein theapparatus comprises an implantable constriction device for gentlyconstricting at least one erectile tissue portion of the patient'serectile tissue to restrict the exit erectile blood flow, a stimulationdevice for stimulating the erectile tissue portion, as the constrictiondevice constricts the erectile tissue portion, to cause contraction ofthe erectile tissue portion to further restrict the exit erectile bloodflow to obtain engorgement with blood of the female erectile tissue,wherein the constriction and stimulation devices form an operableconstriction/stimulation unit, a source of energy, and a control deviceoperable from outside the patient's body to control the source of energyto release energy for use in connection with the operation of theconstriction/stimulation unit.

In a simple form of the invention, the source of energy, such as abattery or accumulator, is implantable in the patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influence by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

The present invention also provides a method for using an apparatus asdescribed above to treat sexual dysfunction of a female patient,comprising providing a wireless remote control adapted to control theconstriction device and/or stimulation device from outside the patient'sbody, and operating the wireless remote control by the patient, when thepatient wants to enhance her sexual arousal.

Pregnancy Control

Egg Movement Control

Another object of the present invention is to provide a pregnancycontrol apparatus for controlling the movement of eggs in the uterinetubes of a female patient. In accordance with this object of the presentinvention, there is provided a pregnancy control apparatus comprising amovement influence device configured to influence the movement of an eggappearing in the lumen of a uterine tube of a female patient, and acontrol device operable to control the movement influence device toinfluence the movement of the egg in the lumen of the uterine tube.

In an embodiment of the invention, the movement influence devicecomprises an implantable constriction device configured to constrict atleast one portion of the uterine tube wall, and the control device isoperable to control the constriction device to constrict the uterinetube wall portion to influence the movement of the egg in the uterinetube. Specifically, the control device is operable to control theconstriction device to constrict the uterine tube wall portion torestrict the lumen of the uterine tube, such that the egg appearing inthe lumen of the uterine tube is prevented from entering the uterinecavity, and to control the constriction device to release the uterinetube such that the egg is allowed to enter the uterine cavity.

In another embodiment of the invention, the constriction device isconfigured to gently constrict the uterine tube wall portion toinfluence the movement of the egg in the uterine tube, the movementinfluence device comprises an implantable stimulation device configuredto stimulate the uterine tube wall portion, and the control device isoperable to control the stimulation device to stimulate the uterine tubewall portion, as the constriction device constricts the uterine tubewall portion, to cause contraction of the uterine tube wall portion tofurther influence the movement of the egg appearing in the uterine tube.Specifically, the constriction device is configured to gently constrictthe uterine tube wall portion to restrict the egg movement in the lumenof the uterine tube, and the control device is operable to control thestimulation device to stimulate the uterine tube wall portion, as theconstriction device constricts the uterine tube wall portion, to causecontraction of the uterine tube wall portion to further restrict the eggmovement in the lumen of the uterine tube.

As a result, the present invention provides an advantageous combinationof constriction and stimulation devices, which results in a two-stageinfluence on the eggs in the uterine tube. Thus, the constriction devicemay gently constrict the uterine tube wall by applying a relatively weakforce against the wall portion, and the stimulation device may stimulatethe constricted wall portion to achieve the desired final influence onthe flow in the uterine tube. The phrase “gently constricting a portionof the uterine tube wall” is to be understood as constricting the wallportion without substantially hampering the blood circulation in theuterine tube wall.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the organ allows tissue of the wall portion to maintainsubstantially normal blood circulation during the operation of theapparatus of the invention.

In most applications using the present invention, there will be dailyadjustments of the implanted constriction device. Therefore, in apreferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionas desired, wherein the control device controls the constriction deviceto adjust the constriction of the wall portion. The control device maycontrol the constriction and stimulation devices independently of eachother, and simultaneously. Optionally, the control device may controlthe stimulation device to stimulate, or to not stimulate the wallportion while the control device controls the constriction device tochange the constriction of the wall portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow of eggs in the uterine tube is obtained.

Flow Restriction

The apparatus of the present invention is well suited for restrictingthe flow of eggs in the uterine tube of a female patient. Thus, in aprincipal embodiment of the invention, the constriction device isadapted to constrict the wall portion to at least restrict the flow inthe uterine tube, and the control device controls the stimulation deviceto cause contraction of the constricted wall portion, so that the flowin the uterine tube is at least further restricted. Specifically, theconstriction device is adapted to constrict the wall portion to aconstricted state in which the blood circulation in the constricted wallportion is substantially unrestricted and the flow in the uterine tubeis at least restricted, and the control device controls the stimulationdevice to cause contraction of the wall portion, so that the flow in theuterine tube is at least further restricted when the wall portion iskept by the constriction device in the constricted state.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the wall portion, such that flow in the uterine tube isrestricted but not stopped, and controls the stimulation device tostimulate the constricted wall portion to cause contraction thereof,such that flow of eggs in the uterine tube is further restricted but notstopped. More precisely, the control device may control the stimulationdevice in a first mode to stimulate the constricted wall portion tofurther restrict but not stop the flow in the uterine tube and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the flow in the uterinetube; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the uterine tube.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat flow in the uterine tube is restricted but not stopped, andcontrols the stimulation device to stimulate the constricted wallportion to cause contraction thereof, such that flow in the uterine tubeis stopped. More precisely, the control device may control thestimulation device in a first mode to stimulate the constricted wallportion to further restrict but not stop the flow in the uterine tubeand to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow in the uterine tube; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the uterine tube.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow of eggs in the uterine tube is substantially stopped, andcontrols the stimulation device to stimulate the constricted wallportion to cause contraction thereof, such that the flow in the uterinetube is completely stopped. More precisely, the control device maycontrol the stimulation device in a first mode to stimulate theconstricted wall portion to completely stop the flow in the uterine tubeand to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow in the uterine tube; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the uterine tube.

For example, the third flow restriction option may be applied where thepresent invention is used for controlling egg flow of a patient who hasdifficulties getting pregnant. Thus, the restriction and stimulationdevices may be implanted on any part of the patient's uterine tubes. Thecontrol device may control the constriction device to gently flatten aportion of the uterine tubes to at least almost completely stop the eggflow in the intestines, and controls the stimulation device to stimulatethe flattened portion to insure that the egg flow is completely stopped.Since the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion,as stated above, the risk of the implanted constriction device injuringthe uterine tubes over time is significantly reduced or even eliminated,and it is insured that the effect of the stimulation is maintained overtime. When the time for getting pregnant is at an optimum, the controldevice controls the constriction and stimulation devices to release theportion of the uterine tubes and cease the stimulation, whereby eggs maypass the portion of the uterine tubes.

Where the stimulation device stimulates the constricted wall portion tocontract, such that the egg flow in the uterine tube is stopped, thecontrol device suitably controls the stimulation device tosimultaneously and cyclically stimulate a first length of theconstricted wall portion and a second length of the constricted wallportion, which is located downstream of the first length, wherein thecontrol device controls the stimulation device to progressivelystimulate the first length in the upstream direction of the uterine tubeand to progressively stimulate the second length in the downstreamdirection of the uterine tube.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the uterine tube, such thatthe flow in the uterine tube remains stopped. Any sensor for sensing aphysical parameter of the patient, such as a pressure in the patient'sbody that relates to the pressure in the uterine tube may be provided,wherein the control device controls the stimulation device in responseto signals from the sensor. Such a sensor may for example sense thepressure in the patient's abdomen, the pressure against the implantedconstriction device or the pressure on the uterine tube wall of thebodily organ.

For example, a pressure sensor may be applied where the presentinvention is used for controlling egg flow of a patient. Thus, theconstriction and stimulation devices may be applied on the patient'suterine tubes

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the uterine tube is stopped. More precisely, thecontrol device may control the constriction device in a first mode toconstrict the constricted wall portion to stop the flow in the uterinetube and in a second mode to cease the constriction of the wall portionto restore flow in the uterine tube. In this case, the control deviceonly controls the stimulation device to stimulate the wall portion whenneeded. A sensor for sensing a physical parameter of the patient's bodythat relates to the pressure in the uterine tube may be provided,wherein the control device controls the stimulation device in responseto signals from the sensor. Such a physical parameter may be a pressurein the patient's abdomen and the sensor may be a pressure sensor.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the patient's wall portion of theuterine tubes in the constricted state. In this case, the control devicemay be used when needed, conveniently by the patient, to control thestimulation device to stimulate the constricted uterine tube wallportion, preferably while adjusting the stimulation intensity, to causecontraction of the wall portion, such that the flow in the uterine tubeis at least further restricted or stopped, and to control thestimulation device to cease the stimulation. More precisely, the controldevice may:

a) control the stimulation device in a first mode to stimulate theconstricted wall portion to further restrict the flow in the uterinetube, and control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the flow in the uterinetube; or

b) control the stimulation device in a first mode to stimulate theconstricted wall portion to stop the flow in the uterine tube, andcontrol the stimulation device in a second mode to cease the stimulationof the wall portion to allow flow in the uterine tube.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions of the uterine tube wall, respectively. The control device maycontrol the constriction device to activate the constriction elements inrandom or in accordance with a predetermined sequence. In this case, thestimulation device includes stimulation elements positioned on theconstriction elements, wherein the control device controls thestimulation device to activate the stimulation elements to stimulate anywall portions of the series of wall portions constricted by saidconstriction elements to contract the organ to close the organ's uterinetube.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence toclose the organ's uterine tube. The design of the constriction device inthe form of a plurality of separate constriction elements makes possibleto counteract growth of hard fibrosis where the constriction device isimplanted.

Movement of Eggs in a Uterine Tube

The apparatus of the invention can be used for actively moving the eggsin the uterine tube of a patient, as described in the embodiments of theinvention listed below.

1) The control device controls the constriction device to close theuterine tube, either at an upstream end or a downstream end of the wallportion, and then controls the constriction device to constrict theremaining part of the wall portion to move the eggs in the uterine tube.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the flowin the uterine tube. The control device controls the stimulation deviceto stimulate the wall portion constricted by the constriction device toclose the uterine tube, either at an upstream end or a downstream end ofthe wall portion, and simultaneously controls the constriction device toincrease the constriction of the wall portion to move the eggs in theuterine tube.

2) The constriction device is adapted to constrict the wall portion torestrict or vary the flow in the uterine tube, and the control devicecontrols the stimulation device to progressively stimulate theconstricted wall portion, in the downstream or upstream direction of theuterine tube, to cause progressive contraction of the wall portion tomove the eggs in the uterine tube.

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion, such that thewall portion is progressively constricted in the downstream or upstreamdirection of the uterine tube to move the eggs in the uterine tube. Theconstriction device may include at least one elongated constrictionelement that extends along the wall portion, wherein the control devicecontrols the elongated constriction element to progressively constrictthe wall portion in the downstream or upstream direction of the uterinetube.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the uterine tube. Suitably, theelongated constriction element comprises contact surfaces dimensioned tocontact a length of the wall portion, when the constriction deviceconstricts the wall portion, and the stimulation device comprises aplurality of stimulation elements distributed along the contactsurfaces, such that the stimulation elements stimulate the differentareas of the wall portion along the length of the wall portion, when thecontrol device controls the stimulation device to stimulate the wallportion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions of the uterine tube wall to at least restrict the flowin the uterine tube. The control device controls the constriction deviceto successively constrict the wall portions of the series of wallportions to move the eggs in the uterine tube in a peristaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the uterine tube wall,respectively. The control device controls the constriction device toactivate the constriction elements one after the other, so that the wallportions of the series of wall portions are successively constrictedalong the organ, whereby the eggs in the uterine tube is moved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the organ to successively constrict the wallportions of the series of wall portions, wherein the control devicecontrols the constriction device to cyclically move the constrictionelement along the wall portions of the series of wall portions.Preferably, the constriction device comprises a plurality ofconstriction elements, each of which is moveable along the wall of theorgan to successively constrict the wall portions of the series of wallportions, wherein the control device controls the constriction device tocyclically move the constriction elements one after the other along thewall portions of the series of wall portions. Specifically, theconstriction device includes a rotor carrying the constriction elements,and the control device controls the rotor to rotate, such that eachconstriction element cyclically constricts the wall portions of theseries of wall portions. Each constriction element suitably comprises aroller for rolling on the wall of the organ to constrict the latter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the uterine tube. Where the constriction deviceincludes at least one constriction element, the stimulation devicesuitably includes at least one stimulation element positioned on theconstriction element for stimulating the wall portion constricted by theconstriction element to close the uterine tube.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the uterinetube.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the uterine tube wall to restrict the flow in theuterine tube, wherein the constriction device includes a plurality ofconstriction elements adapted to constrict the wall portions of theuterine tube wall, respectively, and the stimulation device includesstimulation elements positioned on the constriction elements forstimulating the wall portions constricted by the constriction elementsto close the uterine tube. The control device controls the constrictiondevice to activate the constriction elements to constrict the wallportions of the series of wall portions without completely closing theorgan's uterine tube, and controls the stimulation device to activatethe stimulation elements to stimulate the wall portions one after theother, so that the wall portions of the series of wall portions aresuccessively contracted along the organ to move the eggs in the uterinetube.

6) The constriction device comprises a first constriction element forconstricting the wall portion at an upstream end thereof, a secondconstriction element for constricting the wall portion at a downstreamend thereof, and a third constriction element for constricting the wallportion between the upstream and downstream ends thereof. The controldevice controls the first, second and third constriction elements toconstrict and release the wall portion independently of one another.More specifically, the control device controls the first or secondconstriction element to constrict the wall portion at the upstream ordownstream end thereof to close the uterine tube, and controls the thirdconstriction element to constrict the wall portion between the upstreamand downstream ends thereof, whereby the eggs contained in the wallportion between the upstream and downstream ends thereof is moveddownstream or upstream in the uterine tube. Optionally, the controldevice controls the stimulation device to stimulate the wall portionbetween the upstream and downstream ends thereof, when the thirdconstriction element constricts the wall portion.

6a) In accordance with a first alternative, the control device controlsthe first constriction element to constrict the wall portion at theupstream end thereof to restrict the flow in the uterine tube andcontrols the stimulation device to stimulate the constricted wallportion at the upstream end to close the uterine tube. With the uterinetube closed at the upstream end of the constricted wall portion, thecontrol device controls the third constriction element to constrict thewall portion between the upstream and downstream ends thereof, andoptionally controls the stimulation device to simultaneously stimulatethe wall portion as the latter is constricted by the third constrictionelement. As a result, the eggs contained in the wall portion between theupstream and downstream ends thereof are moved downstream in the uterinetube.

6b) In accordance with a second alternative, the control device controlsthe second constriction element to constrict the wall portion at thedownstream end thereof to restrict the flow in the uterine tube andcontrols the stimulation device to stimulate the constricted wallportion at the downstream end to close the uterine tube. With theuterine tube closed at the downstream end of the constricted wallportion, the control device controls the third constriction element toconstrict the wall portion between the upstream and downstream endsthereof, and optionally controls the stimulation device tosimultaneously stimulate the wall portion as the latter is constrictedby the third constriction element. As a result, the eggs contained inthe wall portion between the upstream and downstream ends thereof aremoved upstream in the uterine tube.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion with electric pulses.

With the tubular shape of the uterine tubes, a particularly long wallportion thereof may be surgically prepared to extend in zigzag withadjacent walls stitched together by two parallel rows of stitches andwith the adjacent walls cut through between the two rows of stitches. Asa result, the uterine tube of this long wall portion of the organ can besignificantly expanded. In this case, the constriction device of theapparatus of the invention is able to move a considerably larger volumeof fluid each time it constricts the long wall portion of the organ.

The various solutions described above under the headline: “Flowrestriction” to stop the flow in the uterine tube of the organ may alsobe used in any of the above noted embodiments (1a), (1b), (4a), (5),(6), (6a) and (6b).

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of theuterine tube, such that at least two of these areas are stimulated atdifferent points of time that is, the stimulation is shifted from onearea to another area over time. In addition, the control device controlsthe stimulation device, such that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before the stimulation device stimulates the areaagain. Furthermore, the control device controls the stimulation deviceto stimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the uterine tube to achieve the desired flowcontrol, while essentially maintaining over time the natural physicalproperties of the uterine tube without risking injuring the organ.

Also, by physically changing the places of stimulation on the organ overtime as described above it is possible to create an advantageouschanging stimulation pattern on the uterine tube, in order to achieve adesired flow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the uterine tube wall during the stimulation thereof, thecontrol device may control the stimulation device to, preferablycyclically, vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with said second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the uterine tube wall portion of the patient'sbodily organ, preferably with electric pulses. This embodiment isparticularly suited for applications in which the wall portion includesmuscle fibers that react to electrical stimula. In this embodiment, thecontrol device controls the stimulation device to stimulate the wallportion with electric pulses preferably in the form of electric pulsetrains, when the wall portion is in the constricted state, to causecontraction of the wall portion. Of course, the configuration of theelectric pulse trains may be similar to the above described pulse trainsand the control device may control the stimulation device toelectrically stimulate the different areas of the wall of the uterinetube in the same manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the uterine tube, such that the elongate patternof electrical elements extends lengthwise along the wall of the uterinetube, and the elements abut the respective areas of the wall portion.The elongate pattern of electrical elements may include one or more rowsof electrical elements extending lengthwise along the wall of theuterine tube. Each row of electrical elements may form a straight,helical or zig-zag path of electrical elements, or any form of path. Thecontrol device may control the stimulation device to successivelyenergize the electrical elements longitudinally along the elongatepattern of electrical elements in a direction opposite to, or in thesame direction as that of, the flow in the patient's uterine tube.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the uterinetube is to be kept closed for a relatively long time, the control devicemay control the stimulation device to energize the electrical elements,such that energized electrical elements form two waves of energizedelectrical elements that simultaneously advance from the center of theconstricted wall portion in two opposite directions towards both ends ofthe elongate pattern of electrical elements. Such waves of energizedelectrical elements can be repeated over and over again without harmingthe uterine tube and without moving fluid or gas in any direction in theuterine tube.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's uterine tubes. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's uterine tube, preferably substantially transverseto the flow direction in the uterine tube. In a third alternative, theelements of the group of energized electrical elements may form morethan two paths of energized electrical elements extending on differentsides of the patient's uterine tube, preferably substantially transverseto the flow direction in the patient's uterine tube.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's organ inthe flow direction in the patient's uterine tube. The electricalelements of each group of electrical elements may form a path ofelements extending at least in part around the patient's uterine tube.In a first alternative, the electrical elements of each group ofelectrical elements may form more than two paths of elements extendingon different sides of the patients uterine tube, preferablysubstantially transverse to the flow direction in the patient's uterinetube. The control device may control the stimulation device to energizethe groups of electrical elements in the series of groups in random, orin accordance with a predetermined pattern. Alternatively, the controldevice may control the stimulation device to successively energize thegroups of electrical elements in the series of groups in a directionopposite to, or in the same direction as that of, the flow in thepatients uterine tube, or in both said directions starting from aposition substantially at the center of the constricted wall portion.For example, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's uterine tube such that theelongate patter of electrical elements extends along the uterine tube inthe same direction as that of the flow in the patient's uterine tube andthe elements abut the respective areas of the wall portion of theuterine tube.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the uterine tube. Thus, the controldevice may control the stimulation device to cool the wall portion, whenthe wall portion is constricted, to cause contraction of the wallportion. For example, the constriction device may constrict the wallportion to at least restrict the flow in the uterine tube, and thecontrol device may control the stimulation device to cool theconstricted wall portion to cause contraction thereof, such that theflow in the uterine tube is at least further restricted, or furtherrestricted but not stopped, or stopped. Alternatively, the controldevice may control the stimulation device to heat the wall portion, whenthe wall portion is constricted and contracted, to cause expansion ofthe wall portion. Where the wall portion includes a blood vessel, thecontrol device may control the stimulation device to cool the bloodvessel to cause contraction thereof, or heat the blood vessel to causeexpansion thereof. Where applicable, thermal stimulation may bepractised in any of the embodiments of the present invention, and thethermal stimulation may be controlled in response to various sensors,for example strain, motion or pressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing uterine tube motion, i.e.natural contractions, uterine tube contractions, pressure sensors forsensing pressure in the organ, strain sensors for sensing strain of theuterine tube, flow sensors for sensing fluid flow in the uterine tube ofthe organ, spectro-photometrical sensors, Ph-sensors for sensing acidityor alkalinity of the fluid in the uterine tube, oxygen-sensors sensorsfor sensing the oxygen content of the fluid in the uterine tube, orsensors for sensing the distribution of the stimulation on thestimulated uterine tube. Any conceivable sensors for sensing any otherkind of useful physical parameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the uterine tube of the patient, wherein the control device controlsthe constriction device and/or stimulation device to change theconstriction of the patient's wall portion in response to the pressuresensor sensing a predetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909, incorporated herein by reference. For example,the control device may control the constriction device and/orstimulation device to change the constriction of the patient's uterinetube wall portion in response to the position sensor sensing that thepatient has assumed a substantially horizontal orientation, i.e. thatthe patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's wall portion to increase or decrease the influence on the flowin the uterine tube during different time periods of the day. In case asensor of any of the above-described types for sensing a physical orfunctional parameter is provided, either the clock mechanism is used forcontrolling the constriction device and/or stimulation device providedthat the parameter sensed by the sensor does not override the clockmechanism, or the sensor is used for controlling the constriction deviceand/or stimulation device provided that the clock mechanism does notoverride the sensor. Suitably, the control device produces anindication, such as a sound signal or displayed information, in responseto signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's uterine tube wall portion, and theconstriction and stimulation devices form a constriction/stimulationunit. Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of a uterine tube wall portion,and the stimulation device of the unit comprises a plurality ofstimulation elements provided on and distributed along the contactsurfaces. When the control device controls the stimulation device tostimulate the wall portion, the stimulation elements stimulate differentareas of the wall portion along the length of the wall portion. Thestimulation elements preferably comprise electric elements, as describedabove, for stimulating the wall portion with electric pulses. However,in most applications of the present invention, other kinds ofstimulations, such as thermal stimulation, could be suitable to employ.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the organ, and the operation deviceoperates the clamping elements to clamp the uterine tube wall portionbetween the clamping elements to constrict the wall portion.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the uterine tube, and the operation device operates the clampingelement to clamp the wall portion between the clamping element and thebone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of theuterine tube, and the operation device rotates the engagement elements,such that the engagement elements engage and constrict the wall portionof the uterine tube.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the uterine tube, and the operation device moves the clampingelements towards each other to clamp the wall portion of the uterinetube between the clamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around theuterine tube, wherein the loop defines a constriction opening. Theoperation device operates the constriction member in the loop to changethe size of the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

7) The constriction device is adapted to bend the wall portion of theuterine tube to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict said length of the uterinetube wall portion of the patient's uterine tube. For this purpose, theconstriction device may include two or more of the describedconstriction elements/members to be applied in a row along said lengthof the wall portion, wherein said row extends in the direction of flowin the uterine tube of the uterine tube. Preferably, such constrictionelements/members are non-inflatable and mechanically operable oradjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the uterine tube assumes a size in theconstricted state that enables the stimulation device to contract thewall portion such that the flow in the uterine tube is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the uterinetube wall portion of the patient's uterine tube, so that the patient'swall portion is constricted upon expansion of the cavity and releasedupon contraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

-   -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members is        operable by magnetic means, hydraulic means, or electric control        means.

2b) The apparatus comprises a fluid conduit between the pump and thecavity, wherein the reservoir forms part of the conduit. The conduit andpump are devoid of any non-return valve. The reservoir forms a fluidchamber with a variable volume, and the pump distributes fluid from thechamber to the cavity by a reduction in the volume of the chamber andwithdraws fluid from the cavity by an expansion of the volume of thechamber. The apparatus further comprises a motor for driving the pump,wherein the pump comprises a movable wall of the reservoir for changingthe volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of theuterine tube. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth, and the hydraulic means may also includea pump and an implantable reservoir containing hydraulic fluid. The pumpdistributes hydraulic fluid from the reservoir to the chambers to movethe clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patients body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling a flow of eggs in a uterine tube formed by auterine tube wall of a patient's uterine tube, wherein the apparatuscomprises an implantable constriction device for gently constricting aportion of the uterine tube wall to influence the flow in the uterinetube, a stimulation device for intermittently and individuallystimulating different areas of the wall portion, as the constrictiondevice constricts the wall portion, to cause contraction of the wallportion to further influence the flow in the uterine tube, wherein theconstriction and stimulation devices form an operableconstriction/stimulation unit, a source of energy, and a control deviceoperable from outside the patient's body to control the source of energyto release energy for use in connection with the operation of theconstriction/stimulation unit. In a simple form of the invention, thesource of energy, such as a battery or accumulator, is implantable inthe patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly Influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

In one embodiment, the apparatus comprises an implantable constrictiondevice for constricting each one of the female's uterine tubes torestrict the passageway thereof, and a control device for controllingsaid constriction device to constrict the uterine tube such that an eggappearing in the passageway of the uterine tube is prevented fromentering the uterine cavity, and to release the uterine tube such thatan egg existing in the passageway of the uterine tube is allowed toenter the uterine cavity. The constriction device may gently constrictat least one portion of the uterine tube wall of the uterine tube torestrict the passageway thereof, and an implantable stimulation devicemay be provided for stimulating the uterine tube wall portion, whereinthe control device controls said stimulation device to stimulate theuterine tube wall portion, as said constriction device constricts theuterine tube wall portion, to cause contraction of the uterine tube wallportion to further restrict the passageway of the uterine tube.

Alternatively, the egg flow control apparatus comprises an implantableconstriction device for gently constricting at least one portion of theuterine tube wall of each one of the female's uterine tubes to restrictthe passageway thereof, a stimulation device for stimulating the uterinetube wall portion of the uterine tube, and a control device forcontrolling said stimulation device to stimulate the uterine tube wallportion, as said constriction device constricts the uterine tube wallportion, to cause contraction of the uterine tube wall portion tofurther restrict the passageway of the uterine tube to prevent an eggexisting in the uterine tube from entering the uterine cavity.

Alternatively, the egg flow control apparatus comprises an implantablestimulation device for stimulating a portion of the uterine tube wall ofeach one of the female's uterine tubes, and a control device forcontrolling said stimulation device to stimulate the uterine tube wallportion of the uterine tube to cause contraction of the uterine tubewall portion, such that the passageway of the uterine tube is restrictedto prevent an egg appearing in the uterine tube from entering theuterine cavity, and to cease stimulating the uterine tube wall portionof the uterine tube to allow an egg existing in the passageway of theuterine tube to enter the uterine cavity.

present invention also provides a method for using an apparatus asdescribed above to control a flow of eggs in a female patient's uterinetube, the method comprising:

-   -   providing a wireless remote control adapted to control the        constriction device and/or stimulation device from outside the        patient's body, and    -   operating the wireless remote control by the patient, when the        patient wants to influence the flow of eggs in the uterine tube.

The present Invention also provides a method for controlling a flow ofeggs in a female patient's uterine tube, the method comprising:

a) gently constricting at least one portion of the uterine tube wall toinfluence the flow in the uterine tube, and

b) stimulating the constricted wall portion to cause contraction of thewall portion to further influence the flow in the uterine tube.

Sperm Movement Control

Another object of the present invention is to provide a pregnancycontrol apparatus for influencing a flow of sperms appearing in thelumen of a uterine tube of a female patient.

In accordance with this object of the present invention, there isprovided a pregnancy control apparatus comprising a flow influencedevice configured to influence a flow of sperms appearing in the lumenof a uterine tube of a female patient, and a control device operable tocontrol the flow Influence device to Influence the flow of sperms in theuterine tube.

In an embodiment of the invention, the flow influence device comprisesan implantable constriction device configured to constrict at least oneportion of the uterine tube wall, and the control device is operable tocontrol the constriction device to constrict the uterine tube wallportion to influence the flow of sperms in the lumen of the uterinetube. Specifically, the constriction device is configured to constrictthe uterine tube to restrict the flow of sperms therein, and the controldevice is operable to control the constriction device to constrict theuterine tube such that the flow of sperms in the uterine tube isstopped, and to control the constriction device to release the uterinetube such that the sperms appearing in the uterine tube are allowed toflow in the uterine tube.

In another embodiment of the invention, the constriction device isconfigured to gently constrict the uterine tube wall portion toinfluence the flow of sperms in the lumen of the uterine tube, the flowinfluence device comprises an implantable stimulation device configuredto stimulate the uterine tube wall portion, and the control device isoperable to control the stimulation device to stimulate the uterine tubewall portion, as the constriction device constricts the uterine tubewall portion, to cause contraction of the uterine tube wall portion tofurther influence the flow of sperms in the uterine tube. Specifically,the constriction device is configured to gently constrict the uterinetube wall portion to restrict the flow of sperms in the uterine tube,and the control device is operable to control the stimulation device tostimulate the uterine tube wall portion, as the constriction deviceconstricts the uterine tube wall portion, to cause contraction of theuterine tube wall portion to further restrict the flow of sperms in theuterine tube.

As a result, the present invention provides an advantageous combinationof constriction and stimulation devices, which results in a two-stageinfluence on the sperms in the uterine tube. Thus, the constrictiondevice may gently constrict the uterine tube wall by applying arelatively weak force against the wall portion, and the stimulationdevice may stimulate the constricted wall portion to achieve the desiredfinal influence on the flow in the uterine tube. The phrase “gentlyconstricting a portion of the uterine tube wall” is to be understood asconstricting the wall portion without substantially hampering the bloodcirculation in the uterine tube wall.

Thus, the apparatus of the invention may help women to avoid pregnancyby influencing the flow of sperms to stop in the uttering tube, therebypreventing the sperm from reaching the egg for a predetermined amount oftime. The lifetime of a sperm is normally 3-5 days. Furthermore thetransportation of egg takes so long time in the uterine tube that anyegg reaching the proximal part of the uterine tube is most likely notviable any more.

Alternatively, the apparatus of the invention may influence the flow ofsperms in the uterine tube such that the sperms are promoted to reachthe egg, whereby the likelihood for pregnancy is increased.

The apparatus may comprise either the constriction device or thestimulation device. Therefore all the embodiments described in thisapplication should be understood to exists in three versions. Onlystimulation device or only constriction device or the combinationthereof. The term uterine tube of course relates to either one orpreferably the two uterine tubes. The device may be used either topromote or prevent pregnancy, affecting the flow of sperm in twodifferent directions, wherein preventing the sperm reaching the eggprevents pregnancy.

The invention therefore includes the following objects:

An apparatus:

for controlling a flow of sperms in an uterine tube of a female patient,the apparatus comprising:

a stimulation device for stimulating the wall portion of the uterinetube wall to constrict and influence the flow of sperm in an uterinetube, and

a control device for controlling the stimulation device to stimulate theuterine tube wall portion, to cause contraction of the uterine tube wallportion to constrict and influence the flow of sperms in the uterinetube.

The stimulation device may be combined with a constriction devicedescribed above in the all the embodiments described herein as well asuse all the different embodiments related to the stimulation devicedescribed herein.

An apparatus:

for controlling a flow of sperms in an uterine tube of a female patient,the apparatus comprising:

an implantable constriction device for constricting at least one portionof the uterine tube wall to at least partly constrict the uterine tube,and

a control device for controlling the constriction device to constrictsthe uterine tube wall portion, to cause contraction of the uterine tubewall portion to influence the flow of sperms in the uterine tube.

The constriction device may be combined with a stimulation devicedescribed above in the all the embodiments described herein, as well asuse all the different embodiments related to the constriction devicedescribed herein.

An apparatus, wherein said the constriction device is adapted toconstrict the wall portion to at least restrict the flow in the uterinetube, and said the control device controls said the stimulation deviceto cause contraction of the constricted wall portion, so that the flowin the uterine tube is at least further restricted.

An apparatus, wherein the constriction device is adapted to constrictthe wall portion to a constricted state in which the blood circulationin the constricted wall portion is substantially unrestricted and theflow in the uterine tube is at least restricted, and the control devicecontrols the stimulation device to cause contraction of the wallportion, so that the flow in the uterine tube is at least furtherrestricted when the wall portion is kept by the constriction device inthe constricted state.

An apparatus, wherein the control device simultaneously controls theconstriction device and the stimulation device.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the organ allows tissue of the wall portion to maintainsubstantially normal blood circulation during the operation of theapparatus of the invention.

In most applications using the present invention, there will be dailyadjustments of the implanted constriction device. Therefore, in apreferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionas desired, wherein the control device controls the constriction deviceto adjust the constriction of the wall portion. The control device maycontrol the constriction and stimulation devices independently of eachother, and simultaneously. Optionally, the control device may controlthe stimulation device to stimulate, or to not stimulate the wallportion while the control device controls the constriction device tochange the constriction of the wall portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow of sperms in the uterine tube is obtained.

Flow Restriction

The apparatus of the present invention is well suited for restrictingthe flow of sperms in the uterine tube of a female patient. Thus, in aprincipal embodiment of the invention, the constriction device isadapted to constrict the wall portion to at least restrict the flow inthe uterine tube, and the control device controls the stimulation deviceto cause contraction of the constricted wall portion, so that the flowin the uterine tube is at least further restricted. Specifically, theconstriction device is adapted to constrict the wall portion to aconstricted state in which the blood circulation in the constricted wallportion is substantially unrestricted and the flow in the uterine tubeis at least restricted, and the control device controls the stimulationdevice to cause contraction of the wall portion, so that the flow in theuterine tube is at least further restricted when the wall portion iskept by the constriction device in the constricted state.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the wall portion, such that flow in the uterine tube isrestricted but not stopped, and controls the stimulation device tostimulate the constricted wall portion to cause contraction thereof,such that flow of sperms in the uterine tube is further restricted butnot stopped. More precisely, the control device may control thestimulation device in a first mode to stimulate the constricted wallportion to further restrict but not stop the flow in the uterine tubeand to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the flow in the uterinetube; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the uterine tube.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat flow in the uterine tube is restricted but not stopped, andcontrols the stimulation device to stimulate the constricted wallportion to cause contraction thereof, such that flow in the uterine tubeis stopped. More precisely, the control device may control thestimulation device in a first mode to stimulate the constricted wallportion to further restrict but not stop the flow in the uterine tubeand to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow in the uterine tube; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the uterine tube.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow of sperms in the uterine tube is substantially stopped,and controls the stimulation device to stimulate the constricted wallportion to cause contraction thereof, such that the flow in the uterinetube is completely stopped. More precisely, the control device maycontrol the stimulation device in a first mode to stimulate theconstricted wall portion to completely stop the flow in the uterine tubeand to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow in the uterine tube; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the uterine tube.

For example, the third flow restriction option may be applied where thepresent invention is used for controlling sperm flow of a patient whohas difficulties getting pregnant. Thus, the restriction and stimulationdevices may be implanted on any part of the patient's uterine tubes. Thecontrol device may control the constriction device to gently flatten aportion of the uterine tubes to at least almost completely stop thesperm flow, and controls the stimulation device to stimulate theflattened portion to insure that the sperm flow is completely stopped.Since the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion,as stated above, the risk of the implanted constriction device injuringthe uterine tubes over time is significantly reduced or even eliminated,and it is insured that the effect of the stimulation is maintained overtime. When the time for getting pregnant is at an optimum, the controldevice controls the constriction and stimulation devices to release theportion of the uterine tubes and cease the stimulation, whereby spermsmay pass the portion of the uterine tubes.

Where the stimulation device stimulates the constricted wall portion tocontract, such that the sperm flow in the uterine tube is stopped, thecontrol device suitably controls the stimulation device tosimultaneously and cyclically stimulate a first length of theconstricted wall portion and a second length of the constricted wallportion, which is located downstream of the first length, wherein thecontrol device controls the stimulation device to progressivelystimulate the first length in the upstream direction of the uterine tubeand to progressively stimulate the second length in the downstreamdirection of the uterine tube.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the uterine tube, such thatthe flow in the uterine tube remains stopped. Any sensor for sensing aphysical parameter of the patient, such as a pressure in the patient'sbody that relates to the pressure in the uterine tube may be provided,wherein the control device controls the stimulation device in responseto signals from the sensor. Such a sensor may for example sense thepressure in the patient's abdomen, the pressure against the implantedconstriction device or the pressure on the uterine tube wall of thebodily organ.

For example, a pressure sensor may be applied where the presentinvention is used for controlling sperm flow of a patient. Thus, theconstriction and stimulation devices may be applied on the patient'suterine tubes

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the uterine tube is stopped. More precisely, thecontrol device may control the constriction device in a first mode toconstrict the constricted wall portion to stop the flow in the uterinetube and in a second mode to cease the constriction of the wall portionto restore flow in the uterine tube. In this case, the control deviceonly controls the stimulation device to stimulate the wall portion whenneeded. A sensor for sensing a physical parameter of the patient's bodythat relates to the pressure in the uterine tube may be provided,wherein the control device controls the stimulation device in responseto signals from the sensor. Such a physical parameter may be a pressurein the patient's abdomen and the sensor may be a pressure sensor.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the patient's wall portion of theuterine tubes in the constricted state. In this case, the control devicemay be used when needed, conveniently by the patient, to control thestimulation device to stimulate the constricted uterine tube wallportion, preferably while adjusting the stimulation intensity, to causecontraction of the wall portion, such that the flow in the uterine tubeis at least further restricted or stopped, and to control thestimulation device to cease the stimulation. More precisely, the controldevice may:

a) control the stimulation device in a first mode to stimulate theconstricted wall portion to further restrict the flow in the uterinetube, and control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the flow in the uterinetube; or

b) control the stimulation device in a first mode to stimulate theconstricted wall portion to stop the flow in the uterine tube, andcontrol the stimulation device in a second mode to cease the stimulationof the wall portion to allow flow in the uterine tube.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions of the uterine tube wall, respectively. The control device maycontrol the constriction device to activate the constriction elements inrandom or in accordance with a predetermined sequence. In this case, thestimulation device includes stimulation elements positioned on theconstriction elements, wherein the control device controls thestimulation device to activate the stimulation elements to stimulate anywall portions of the series of wall portions constricted by theconstriction elements to contract the organ to close the organ's uterinetube.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence toclose the organ's uterine tube. The design of the constriction device inthe form of a plurality of separate constriction elements makes possibleto counteract growth of hard fibrosis where the constriction device isimplanted.

Movement of Sperms in a Uterine Tube

The apparatus of the invention can be used for actively moving thesperms in the uterine tube of a patient, as described in the embodimentsof the invention listed below. Either to promote or prevent pregnancy.

1) The control device controls the constriction device to close theuterine tube, either at an upstream end or a downstream end of the wallportion, and then controls the constriction device to constrict theremaining part of the wall portion to move the sperms in the uterinetube.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the flowin the uterine tube. The control device controls the stimulation deviceto stimulate the wall portion constricted by the constriction device toclose the uterine tube, either at an upstream end or a downstream end ofthe wall portion, and simultaneously controls the constriction device toincrease the constriction of the wall portion to move the sperms in theuterine tube.

2) The constriction device is adapted to constrict the wall portion torestrict or vary the flow in the uterine tube, and the control devicecontrols the stimulation device to progressively stimulate theconstricted wall portion, in the downstream or upstream direction of theuterine tube, to cause progressive contraction of the wall portion tomove the sperms in the uterine tube.

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion, such that thewall portion is progressively constricted in the downstream or upstreamdirection of the uterine tube to move the sperms in the uterine tube.The constriction device may include at least one elongated constrictionelement that extends along the wall portion, wherein the control devicecontrols the elongated constriction element to progressively constrictthe wall portion in the downstream or upstream direction of the uterinetube.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the uterine tube. Suitably, theelongated constriction element comprises contact surfaces dimensioned tocontact a length of the wall portion, when the constriction deviceconstricts the wall portion, and the stimulation device comprises aplurality of stimulation elements distributed along the contactsurfaces, such that the stimulation elements stimulate the differentareas of the wall portion along the length of the wall portion, when thecontrol device controls the stimulation device to stimulate the wallportion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions of the uterine tube wall to at least restrict the flowin the uterine tube. The control device controls the constriction deviceto successively constrict the wall portions of the series of wallportions to move the sperms in the uterine tube in a peristaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the uterine tube wall,respectively. The control device controls the constriction device toactivate the constriction elements one after the other, so that the wallportions of the series of wall portions are successively constrictedalong the organ, whereby the sperms in the uterine tube is moved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the organ to successively constrict the wallportions of the series of wall portions, wherein the control devicecontrols the constriction device to cyclically move the constrictionelement along the wall portions of the series of wall portions.Preferably, the constriction device comprises a plurality ofconstriction elements, each of which is moveable along the wall of theorgan to successively constrict the wall portions of the series of wallportions, wherein the control device controls the constriction device tocyclically move the constriction elements one after the other along thewall portions of the series of wall portions. Specifically, theconstriction device includes a rotor carrying the constriction elements,and the control device controls the rotor to rotate, such that eachconstriction element cyclically constricts the wall portions of theseries of wall portions. Each constriction element suitably comprises aroller for rolling on the wall of the organ to constrict the latter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the uterine tube. Where the constriction deviceincludes at least one constriction element, the stimulation devicesuitably includes at least one stimulation element positioned on theconstriction element for stimulating the wall portion constricted by theconstriction element to close the uterine tube.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the uterinetube.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the uterine tube wall to restrict the flow in theuterine tube, wherein the constriction device includes a plurality ofconstriction elements adapted to constrict the wall portions of theuterine tube wall, respectively, and the stimulation device includesstimulation elements positioned on the constriction elements forstimulating the wall portions constricted by the constriction elementsto close the uterine tube. The control device controls the constrictiondevice to activate the constriction elements to constrict the wallportions of the series of wall portions without completely closing theorgan's uterine tube, and controls the stimulation device to activatethe stimulation elements to stimulate the wall portions one after theother, so that the wall portions of the series of wall portions aresuccessively contracted along the organ to move the sperms in theuterine tube.

6) The constriction device comprises a first constriction element forconstricting the wall portion at an upstream end thereof, a secondconstriction element for constricting the wall portion at a downstreamend thereof, and a third constriction element for constricting the wallportion between the upstream and downstream ends thereof. The controldevice controls the first, second and third constriction elements toconstrict and release the wall portion independently of one another.More specifically, the control device controls the first or secondconstriction element to constrict the wall portion at the upstream ordownstream end thereof to close the uterine tube, and controls the thirdconstriction element to constrict the wall portion between the upstreamand downstream ends thereof, whereby the sperms contained in the wallportion between the upstream and downstream ends thereof is moveddownstream or upstream in the uterine tube. Optionally, the controldevice controls the stimulation device to stimulate the wall portionbetween the upstream and downstream ends thereof, when the thirdconstriction element constricts the wall portion.

-   -   6a) In accordance with a first alternative, the control device        controls the first constriction element to constrict the wall        portion at the upstream end thereof to restrict the flow in the        uterine tube and controls the stimulation device to stimulate        the constricted well portion at the upstream end to close the        uterine tube. With the uterine tube closed at the upstream end        of the constricted wall portion, the control device controls the        third constriction element to constrict the wall portion between        the upstream and downstream ends thereof, and optionally        controls the stimulation device to simultaneously stimulate the        wall portion as the latter is constricted by the third        constriction element. As a result, the sperms contained in the        wall portion between the upstream and downstream ends thereof        are moved downstream in the uterine tube.    -   6b) In accordance with a second alternative, the control device        controls the second constriction element to constrict the wall        portion at the downstream end thereof to restrict the flow in        the uterine tube and controls the stimulation device to        stimulate the constricted wall portion at the downstream end to        close the uterine tube. With the uterine tube closed at the        downstream end of the constricted wall portion, the control        device controls the third constriction element to constrict the        wall portion between the upstream and downstream ends thereof,        and optionally controls the stimulation device to simultaneously        stimulate the wall portion as the latter is constricted by the        third constriction element. As a result, the sperms contained in        the wall portion between the upstream and downstream ends        thereof are moved upstream in the uterine tube.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion with electric pulses.

With the tubular shape of the uterine tubes, a particularly long wallportion thereof may be surgically prepared to extend in zigzag withadjacent walls stitched together by two parallel rows of stitches andwith the adjacent walls cut through between the two rows of stitches. Asa result, the uterine tube of this long wall portion of the organ can besignificantly expanded. In this case, the constriction device of theapparatus of the invention is able to move a considerably larger volumeof fluid each time it constricts the long wall portion of the organ.

The various solutions described above under the headline: “Flowrestriction” to stop the flow in the uterine tube of the organ may alsobe used in any of the above noted embodiments (1a), (1b), (4a), (5),(6), (6a) and (6b).

To summarize a few preferred embodiments see below:

In accordance with an object any wall portions of a series of wallportions of the organ's tissue wall, respectively. In accordance with analternative, the wall portions of the series of wall portions areconstricted in random or in accordance with a predetermined sequence. Inaccordance with an alternative, the wall portions of the series of wallportions are successively constricted along the organ to move the spermin the lumen of the patient's organ or to prevent the fluid and/or otherbodily matter to move in the lumen of the patient's organ.

In accordance with an alternative, step (b) is performed by stimulatingany constricted wall portions of the series of wall portions. Inaccordance with an alternative, the wall portions of the series of wallportions are constricted in random or in accordance with a predeterminedsequence. In accordance with an alternative, wherein the wall portionsof the series of wall portions are successively constricted along theorgan to move the fluid and/or other bodily matter in the lumen of thepatient's organ or to prevent the fluid and/or other bodily matter tomove in the lumen of the patient's organ.

In accordance with an alternative, step (a) is performed by constrictingany wall portions of a series of wall portions of the organ's tissuewall, respectively, wherein the wall portions of the series of wallportions are succesively constricted without completely closing theorgan's lumen, and step (b) is performed by stimulating the constrictedwall portions, so that the wall portions of the series of wall portionsare further constricted. In accordance with an alternative, the wallportions of the series of wall portions are constricted in random or inaccordance with a predetermined sequence.

In accordance with an alternative, wherein the wall portions of theseries of wall portions are successively constricted along the organ tomove the fluid and/or other bodily matter in the lumen of the patient'sorgan or to prevent the fluid and/or other bodily matter to move in thelumen of the patient's organ.

In accordance with an alternative, step (a) is performed by constrictingall of the wall portions of the series of wall portions, and step (b) isperformed by stimulating any constricted wall portions so that the wallportions of the series of wall portions are further constricted.

In accordance with an alternative, the wall portions of the series ofwall portions are further constricted by the stimulation device inrandom or in accordance with a predetermined sequence.

In accordance with an alternative, the wall portions of the series ofwall portions are successively further constricted by the stimulationdevice along the organ to move the fluid and/or other bodily matter inthe lumen of the patient's organ or to prevent the fluid and/or otherbodily matter to move in the lumen of the patient's organ.

In accordance with an alternative for all apllicabel alternatives, step(a) and step (b) are performed independently of each other or inaccordance with an alternative, step (a) and step (b) are performedsimultaneously.

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of theuterine tube, such that at least two of these areas are stimulated atdifferent points of time that is, the stimulation is shifted from onearea to another area over time. In addition, the control device controlsthe stimulation device, such that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before the stimulation device stimulates the areaagain. Furthermore, the control device controls the stimulation deviceto stimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the uterine tube to achieve the desired flowcontrol, while essentially maintaining over time the natural physicalproperties of the uterine tube without risking injuring the organ.

Also, by physically changing the places of stimulation on the organ overtime as described above it is possible to create an advantageouschanging stimulation pattern on the uterine tube, in order to achieve adesired flow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the uterine tube wall during the stimulation thereof, thecontrol device may control the stimulation device to, preferablycyclically, vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with the second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the uterine tube wall portion of the patient'sbodily organ, preferably with electric pulses. This embodiment isparticularly suited for applications in which the wall portion includesmuscle fibers that react to electrical stimula. In this embodiment, thecontrol device controls the stimulation device to stimulate the wallportion with electric pulses preferably in the form of electric pulsetrains, when the wall portion is in the constricted state, to causecontraction of the wall portion. Of course, the configuration of theelectric pulse trains may be similar to the above described pulse trainsand the control device may control the stimulation device toelectrically stimulate the different areas of the wall of the uterinetube in the same manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the uterine tube, such that the elongate patternof electrical elements extends lengthwise along the wall of the uterinetube, and the elements abut the respective areas of the wall portion.The elongate pattern of electrical elements may include one or more rowsof electrical elements extending lengthwise along the wall of theuterine tube. Each row of electrical elements may form a straight,helical or zig-zag path of electrical elements, or any form of path. Thecontrol device may control the stimulation device to successivelyenergize the electrical elements longitudinally along the elongatepattern of electrical elements in a direction opposite to, or in thesame direction as that of, the flow in the patient's uterine tube.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the uterinetube is to be kept closed for a relatively long time, the control devicemay control the stimulation device to energize the electrical elements,such that energized electrical elements form two waves of energizedelectrical elements that simultaneously advance from the center of theconstricted wall portion in two opposite directions towards both ends ofthe elongate pattern of electrical elements. Such waves of energizedelectrical elements can be repeated over and over again without harmingthe uterine tube and without moving fluid or gas in any direction in theuterine tube.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's uterine tubes. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's uterine tube, preferably substantially transverseto the flow direction in the uterine tube. In a third alternative, theelements of the group of energized electrical elements may form morethan two paths of energized electrical elements extending on differentsides of the patient's uterine tube, preferably substantially transverseto the flow direction in the patient's uterine tube.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's organ inthe flow direction in the patient's uterine tube. The electricalelements of each group of electrical elements may form a path ofelements extending at least in part around the patient's uterine tube.In a first alternative, the electrical elements of each group ofelectrical elements may form more than two paths of elements extendingon different sides of the patient's uterine tube, preferablysubstantially transverse to the flow direction in the patient's uterinetube. The control device may control the stimulation device to energizethe groups of electrical elements in the series of groups in random, orin accordance with a predetermined pattern. Alternatively, the controldevice may control the stimulation device to successively energize thegroups of electrical elements in the series of groups in a directionopposite to, or in the same direction as that of, the flow in thepatient's uterine tube, or in both the directions starting from aposition substantially at the center of the constricted wall portion.For example, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's uterine tube such that theelongate pattern of electrical elements extends along the uterine tubein the same direction as that of the flow in the patient's uterine tubeand the elements abut the respective areas of the wall portion of theuterine tube.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the uterine tube. Thus, the controldevice may control the stimulation device to cool the wall portion, whenthe wall portion is constricted, to cause contraction of the wallportion. For example, the constriction device may constrict the wallportion to at least restrict the flow in the uterine tube, and thecontrol device may control the stimulation device to cool theconstricted wall portion to cause contraction thereof, such that theflow in the uterine tube is at least further restricted, or furtherrestricted but not stopped, or stopped. Alternatively, the controldevice may control the stimulation device to heat the wall portion, whenthe wall portion is constricted and contracted, to cause expansion ofthe wall portion. Where the wall portion includes a blood vessel, thecontrol device may control the stimulation device to cool the bloodvessel to cause contraction thereof, or heat the blood vessel to causeexpansion thereof. Where applicable, thermal stimulation may bepractised in any of the embodiments of the present invention, and thethermal stimulation may be controlled in response to various sensors,for example strain, motion or pressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing uterine tube motion, i.e.natural contractions, uterine tube contractions, pressure sensors forsensing pressure in the organ, strain sensors for sensing strain of theuterine tube, flow sensors for sensing fluid flow in the uterine tube ofthe organ, spectro-photometrical sensors, Ph-sensors for sensing acidityor alkalinity of the fluid in the uterine tube, oxygen-sensors sensorsfor sensing the oxygen content of the fluid in the uterine tube, orsensors for sensing the distribution of the stimulation on thestimulated uterine tube. Any conceivable sensors for sensing any otherkind of useful physical parameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the uterine tube of the patient, wherein the control device controlsthe constriction device and/or stimulation device to change theconstriction of the patient's wall portion in response to the pressuresensor sensing a predetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909, incorporated herein by reference. For example,the control device may control the constriction device and/orstimulation device to change the constriction of the patient's uterinetube wall portion in response to the position sensor sensing that thepatient has assumed a substantially horizontal orientation, i.e. thatthe patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's wall portion to increase or decrease the influence on the flowin the uterine tube during different time periods of the day. In case asensor of any of the above-described types for sensing a physical orfunctional parameter is provided, either the clock mechanism is used forcontrolling the constriction device and/or stimulation device providedthat the parameter sensed by the sensor does not override the clockmechanism, or the sensor is used for controlling the constriction deviceand/or stimulation device provided that the clock mechanism does notoverride the sensor. Suitably, the control device produces anindication, such as a sound signal or displayed information, in responseto signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's uterine tube wall portion, and theconstriction and stimulation devices form a constriction/stimulationunit. Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of a uterine tube wall portion,and the stimulation device of the unit comprises a plurality ofstimulation elements provided on and distributed along the contactsurfaces. When the control device controls the stimulation device tostimulate the wall portion, the stimulation elements stimulate differentareas of the wall portion along the length of the wall portion. Thestimulation elements preferably comprise electric elements, as describedabove, for stimulating the wall portion with electric pulses. However,in most applications of the present invention, other kinds ofstimulations, such as thermal stimulation, could be suitable to employ.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the organ, and the operation deviceoperates the clamping elements to clamp the uterine tube wall portionbetween the clamping elements to constrict the wall portion.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the uterine tube, and the operation device operates the clampingelement to clamp the wall portion between the clamping element and thebone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of theuterine tube, and the operation device rotates the engagement elements,such that the engagement elements engage and constrict the wall portionof the uterine tube.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the uterine tube, and the operation device moves the clampingelements towards each other to clamp the wall portion of the uterinetube between the clamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around theuterine tube, wherein the loop defines a constriction opening. Theoperation device operates the constriction member in the loop to changethe size of the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

7) The constriction device is adapted to bend the wall portion of theuterine tube to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict the length of the uterinetube wall portion of the patient's uterine tube. For this purpose, theconstriction device may include two or more of the describedconstriction elements/members to be applied in a row along the length ofthe wall portion, wherein the row extends in the direction of flow inthe uterine tube of the uterine tube. Preferably, such constrictionelements/members are non-inflatable and mechanically operable oradjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the uterine tube assumes a size in theconstricted state that enables the stimulation device to contract thewall portion such that the flow in the uterine tube is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the uterinetube wall portion of the patient's uterine tube, so that the patient'swall portion is constricted upon expansion of the cavity and releasedupon contraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

-   -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members is        operable by magnetic means, hydraulic means, or electric control        means.

2b) The apparatus comprises a fluid conduit between the pump and thecavity, wherein the reservoir forms part of the conduit. The conduit andpump are devoid of any non-return valve. The reservoir forms a fluidchamber with a variable volume, and the pump distributes fluid from thechamber to the cavity by a reduction in the volume of the chamber andwithdraws fluid from the cavity by an expansion of the volume of thechamber. The apparatus further comprises a motor for driving the pump,wherein the pump comprises a movable wall of the reservoir for changingthe volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of theuterine tube. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth, and the hydraulic means may also includea pump and an implantable reservoir containing hydraulic fluid. The pumpdistributes hydraulic fluid from the reservoir to the chambers to movethe clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling a flow of sperms in a uterine tube formed by auterine tube wall of a patient's uterine tube, wherein the apparatuscomprises an implantable constriction device for gently constricting aportion of the uterine tube wall to influence the flow in the uterinetube, a stimulation device for intermittently and individuallystimulating different areas of the wall portion, as the constrictiondevice constricts the wall portion, to cause contraction of the wallportion to further influence the flow in the uterine tube, wherein theconstriction and stimulation devices form an operableconstriction/stimulation unit, a source of energy, and a control deviceoperable from outside the patient's body to control the source of energyto release energy for use in connection with the operation of theconstriction/stimulation unit. In a simple form of the invention, thesource of energy, such as a battery or accumulator, is implantable inthe patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patients body and the control devicecontrols the external source of energy to release wireless energy. Inthis sophisticated form of the invention, the apparatus comprises anenergy-transmission device that transmits the released wireless energyfrom outside the patient's body to inside the patient's body. Among manythings the wireless energy may comprise electromagnetic energy, anelectric field, an electromagnetic field or a magnetic field, or acombination thereof, or electromagnetic waves. The energy-transmissiondevice may transmit wireless energy for direct use in connection withthe operation of the constriction/stimulation unit, as the wirelessenergy is being transmitted. For example, where an electric motor orpump operates the constriction device, wireless energy in the form of amagnetic or an electromagnetic field may be used for direct power of themotor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

In one embodiment, the apparatus comprises an implantable constrictiondevice for constricting each one of the female's uterine tubes torestrict the passageway thereof, and a control device for controllingthe constriction device to constrict the uterine tube such that an spermappearing in the passageway of the uterine tube is prevented fromentering the uterine cavity, and to release the uterine tube such thatan sperm existing in the passageway of the uterine tube is allowed toenter the uterine cavity. The constriction device may gently constrictat least one portion of the uterine tube wall of the uterine tube torestrict the passageway thereof, and an implantable stimulation devicemay be provided for stimulating the uterine tube wall portion, whereinthe control device controls the stimulation device to stimulate theuterine tube wall portion, as the constriction device constricts theuterine tube wall portion, to cause contraction of the uterine tube wallportion to further restrict the passageway of the uterine tube.

Alternatively, the sperm flow control apparatus comprises an implantableconstriction device for gently constricting at least one portion of theuterine tube wall of each one of the female's uterine tubes to restrictthe passageway thereof, a stimulation device for stimulating the uterinetube wall portion of the uterine tube, and a control device forcontrolling the stimulation device to stimulate the uterine tube wallportion, as the constriction device constricts the uterine tube wallportion, to cause contraction of the uterine tube wall portion tofurther restrict the passageway of the uterine tube to prevent an spermexisting in the uterine tube from entering the uterine cavity.

Alternatively, the sperm flow control apparatus comprises an implantablestimulation device for stimulating a portion of the uterine tube wall ofeach one of the female's uterine tubes, and a control device forcontrolling the stimulation device to stimulate the uterine tube wallportion of the uterine tube to cause contraction of the uterine tubewall portion, such that the passageway of the uterine tube is restrictedto prevent an sperm appearing in the uterine tube from entering theuterine cavity, and to cease stimulating the uterine tube wall portionof the uterine tube to allow an sperm existing in the passageway of theuterine tube to enter the uterine cavity.

The present invention also provides a method for using an apparatus asdescribed above to control a flow of sperms in a female patient'suterine tube, the method comprising:

providing a wireless remote control adapted to control the constrictiondevice and/or stimulation device from outside the patient's body, and

operating the wireless remote control by the patient, when the patientwants to influence the flow of sperms in the uterine tube.

The present invention also provides a method for controlling a flow ofsperms in a female patient's uterine tube, the method comprising:

a) gently constricting at least one portion of the uterine tube wall toinfluence the flow in the uterine tube, and

b) stimulating the constricted wall portion to cause contraction of thewall portion to further influence the flow of sperm in the uterine tube.

General Method

The present invention also provides a method for controlling a flow ofsperms in a female patient's uterine tube, the method comprising:

stimulating the wall portion to cause contraction of the wall portion toinfluence the flow of sperm in the uterine tube.

The stimulation device may be combined with a constriction devicedescribed above in the all the method embodiments described herein aswell as use all the different method embodiments related to thestimulation device described herein.

The present Invention also provides a method for controlling a flow ofsperms in a female patient's uterine tube, the method comprising:

constricting at least one portion of the uterine tube wall to influencethe flow of sperm in the uterine tube.

The constriction device may be combined with a stimulation device in theall the method embodiments described herein, as well as use all thedifferent method embodiments related to the constriction device andmethods described herein.

Laparoscopic Method

The method for controlling a flow of sperm in a lumen formed by a tissuewall of a patient's uterine tube, the method comprising the steps of:

inserting a needle like tube into a cavity of the patients body,

using the needle like tube to fill the cavity with gas thereby expandingthe I cavity,

placing at least two laparoscopical trocars in the patient's body,

inserting a camera through one of the trocars into the cavity,

inserting a dissecting tool through any of the trocar and dissecting anarea of at least one portion of the tissue wall of the uterine tube,

placing a constriction device and a stimulation device in the dissectedarea in operative engagement with the uterine tube,

using the constriction device to gently constrict the wall portion ofthe uterine tube to influence the flow in the lumen, and

using the stimulation device to stimulate the constricted wall portionto cause contraction of the wall portion to further influence the flowin the lumen.

The method for controlling a flow of sperm in a lumen formed by a tissuewall of a patient's uterine tube, the method comprising the steps of:

inserting a needle like tube into a cavity of the patients body,

using the needle like tube to fill the cavity with gas thereby expandingthe cavity,

placing at least two laparoscopical trocars in the patient's body,

inserting a camera through one of the trocars into the cavity,

inserting a dissecting tool through any of the trocar and dissecting anarea of at least one portion of the tissue wall of the uterine tube,

placing a stimulation device in the dissected area in operativeengagement with the uterine tube, and

using the stimulation device to stimulate the wall portion to causecontraction of the wall portion to influence the flow in the lumen.

The method for controlling a flow of sperm in a lumen formed by a tissuewall of a patient's uterine tube, the method comprising the steps of:

inserting a needle like tube into a cavity of the patients body,

using the needle like tube to fill the cavity with gas thereby expandingthe cavity,

placing at least two laparoscopical trocars in the patient's body,

inserting a camera through one of the trocars into the cavity,

inserting a dissecting tool through any of the trocar and dissecting anarea of at least one portion of the tissue wall of the uterine tube,

placing a constriction device in the dissected area in operativeengagement with the uterine tube,

using the constriction device to constrict the wall portion of theuterine tube to influence the flow in the lumen.

The method for controlling a flow of uterine tube in a lumen formed by atissue wall of a patient's uterine tube, the method comprising the stepsof:

cutting the skin of the patient,

inserting a dissecting tool and dissecting an area of at least oneportion of the tissue wall of the uterine tube,

placing a constriction device and a stimulation device in the dissectedarea in operative engagement with the uterine tube,

using the constriction device to gently constrict the wall portion ofthe uterine tube to influence the flow in the lumen, and

using the stimulation device to stimulate the constricted wall portionto cause contraction of the wall portion to further influence the flowin the lumen.

The method for controlling a flow of sperm in a lumen formed by a tissuewall of a patient's uterine tube, the method comprising the steps of:

cutting the skin of the patient,

inserting a dissecting tool and dissecting an area of at least oneportion of the tissue wall of the uterine tube,

placing a stimulation device in the dissected area in operativeengagement with the uterine tube, and

using the stimulation device to stimulate the wall portion to causecontraction of the wall portion to influence the flow in the lumen.

The method for controlling a flow of sperm in a lumen formed by a tissuewall of a patient's uterine tube, the method comprising the steps of:

cutting the skin of the patient,

inserting a dissecting tool and dissecting an area of at least oneportion of the tissue wall of the organ,

placing a constriction device in the dissected area in operativeengagement with the uterine tube, and

using the constriction device to constrict the wall portion of theuterine tube to influence the flow in the lumen.

The method according to any one of the six method embodiment above,wherein the cavity comprising: at least one of an abdominal cavity, acavity in the pelvic region, a cavity in human soft tissue such asmuscle, fat and fibrotic tissue.

The further method embodiments could used to any of the above:

The method according, further comprising implanting a powered operationdevice for operating the constriction device.

The method, wherein the operation device comprises a powered hydraulicoperation device.

The method, wherein the operation device comprises an electricallypowered operation device.

The method, wherein the operation device comprises an electric motor.

The method, further comprising transmitting wireless energy for poweringthe operation device, and when desired to influence the flow in thepatient's uterine tube, powering the operation device with thetransmitted energy to operate the constriction device.

The method, further comprising implanting a source of energy in thepatient, providing an external source of energy, controlling theexternal source of energy to release wireless energy, transforming thewireless energy into storable energy, non-invasively charging theimplanted source of energy with the transformed energy, and controllingthe implanted source of energy from outside the patient's body torelease energy for use in connection with the operation of theconstriction device and/or stimulation device.

The method, wherein the wireless energy is transformed into a storableenergy different from the wireless energy.

Preventing Flow or Promoting Flow

First, the apparatus, wherein the flow influence device comprising oneor more restriction devices, adapted to contract more than one tissuewall portion, wherein the one or more restriction devices is adapted torestrict a series of wall portions of the uterine tube's tissue wall.

Second, the apparatus wherein the restriction device comprising aconstriction device for restricting the wall portions of the series ofwall portions, adapted to restrict the wall portions of the series ofwall portions in random or in accordance with a predetermined sequence.

Third, the apparatus, wherein the restriction device comprising aconstriction device for restricting the wall portions of the series ofwall portions and further comprising a stimulation device for furtherrestricting any constricted wall portions of the series of wallportions, in random or in accordance with a predetermined sequence.

Fourth, the apparatus, wherein the restriction device, comprising aconstriction device, for constricting without completely closing theuterine tube's lumen, and further comprising a stimulation device forstimulating the constricted wall portions one after the other, so thatthe wall portions of the series of wall portions are successivelyrestricted along the uterine tube, in random or in accordance with apredetermined sequence.

Fifth, the apparatus, wherein the restriction device, comprising astimulation device for stimulating any wall portion of a series of wallportions to restrict the wall portions of the series of wall portions inrandom or in accordance with a predetermined sequence.

Sixth, the apparatus, wherein the restriction device, comprising aconstriction device for restricting all of the wall portions of theseries of wall portions, and a stimulating device for stimulating anyrestricted wall portions in random or in accordance with a predeterminedsequence to close the uterine tube's lumen.

The apparatus, as described in all six objects above, wherein thecontrol device is adapted to control the one or more restriction devicesto restrict the wall portions of the series of wall portions at leasttwo at a time with the restrictions placed spaced apart, wherein thecontrol device is adapted to successively restrict the wall portions ofthe series of wall portions along the uterine tube to move the sperm inthe lumen of the patient's uretine tube or to prevent the sperm to movein the lumen of the patient's uterine tube.

The apparatus, as described in all six objects above, wherein thecontrol device is adapted to successively restrict the wall portions ofthe series of wall portions along the uterine tube to move the sperm inthe lumen of the patient's uretine tube or to prevent the sperm to movein the lumen of the patient's uterine tube.

Blood Flow Control

Another object of the present invention is to provide a blood flowcontrol apparatus for controlling the flow or blood in blood vessels, soas to at least substantially or even completely eliminate the injuredtissue wall problems that have resulted from implanted prior art devicesthat constrict such blood vessels. It is another object to obviate atleast some of the remaining drawbacks of the prior art.

In accordance with the object of the present invention, there isprovided a blood flow control apparatus for controlling the flow ofblood and/or other bodily matter in a patient's blood vessel, theapparatus comprising an implantable constriction device configured togently constrict at least one portion of the tissue wall of the bloodvessel to influence the flow in the blood vessel, a stimulation deviceconfigured to stimulate the wall portion of the tissue wall, and acontrol device operable to control the stimulation device to stimulatethe wall portion, as the constriction device constricts the wallportion, to cause contraction of the wall portion to further influencethe flow in the blood vessel.

The present invention provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stageinfluence on the flow of blood in a blood vessel. Thus, the constrictiondevice gently constricts the wall of the blood vessel by applying arelatively weak force against the wall portion, and the stimulationdevice stimulates the constricted wall portion to achieve the desiredfinal influence on the flow in the blood vessel. The phrase “gentlyconstricting a portion of the wall of the blood vessel” is to beunderstood as constricting the wall portion without injuring the bloodvessel.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the blood vessel allows tissue of the wall portion tomaintain substantially normal blood circulation during the operation ofthe apparatus of the invention.

The combination of the constriction and stimulation devices enablesapplication of the apparatus of the invention at any place on any kindof blood vessels, which is a significant advance in the art, as comparedwith prior stimulation devices that are confined to electricstimulation.

In most applications using the present invention, there will be dailyadjustments of the implanted constriction device. Therefore, in apreferred embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionas desired, wherein the control device controls the constriction deviceto adjust the constriction of the wall portion. The control device maycontrol the constriction and stimulation devices independently of eachother, and simultaneously. Optionally, the control device may controlthe stimulation device to stimulate, or to not stimulate the wallportion while the control device controls the constriction device tochange the constriction of the wall portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow in the blood vessel is obtained.

Flow Restriction

The apparatus of the present invention is well suited for restrictingthe flow of blood in a blood vessel. Thus, in a principal embodiment ofthe invention, the constriction device is configured to constrict thewall portion to at least restrict the flow in the vessel, and thecontrol device is operable to control the stimulation device to causecontraction of the constricted wall portion, so that the flow in theblood vessel is at least further restricted. Specifically, theconstriction device is configured to constrict the wall portion to aconstricted state in which the blood circulation in the constricted wallportion is substantially unrestricted and the flow in the blood vesselis at least restricted, and the control device is operable to controlthe stimulation device to cause an increase of the tonus of the bloodvessel, so that the flow in the blood vessel is at least furtherrestricted when the wall portion is kept by the constriction device inthe constricted state.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the wall portion, such that flow in the blood vessel isrestricted but not stopped, and controls the stimulation device tostimulate the constricted wall portion to cause contraction thereof,such that flow in the blood vessel is further restricted but notstopped. More precisely, the control device may control the stimulationdevice in a first mode to stimulate the constricted wall portion tofurther restrict but not stop the flow in the blood vessel and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the flow in the bloodvessel; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the blood vessel.

In accordance with a flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat flow in the blood vessel is restricted but not stopped, andcontrols the stimulation device to stimulate the constricted wallportion to cause contraction thereof, such that flow in the blood vesselis stopped. More precisely, the control device may control thestimulation device in a first mode to stimulate the constricted wallportion to further restrict but not stop the flow in the blood vesseland to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow in the blood vessel; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the blood vessel.

In accordance with another flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the blood vessel is substantially stopped, and controlsthe stimulation device to stimulate the constricted wall portion tocause contraction thereof, such that the flow in the blood vessel iscompletely stopped. More precisely, the control device may control thestimulation device in a first mode to stimulate the constricted wallportion to completely stop the flow in the blood vessel and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow flow in the blood vessel; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the blood vessel.

Where the stimulation device stimulates the constricted wall portion tocontract, such that the flow in the blood vessel is stopped, the controldevice suitably controls the stimulation device to simultaneously andcyclically stimulate a first length of the constricted wall portion anda second length of the constricted wall portion, which is locateddownstream of the first length, wherein the control device controls thestimulation device to progressively stimulate the first length in theupstream direction of the blood vessel and to progressively stimulatethe second length in the downstream direction of the blood vessel.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the blood vessel, such thatthe flow in the blood vessel remains stopped. Any sensor for sensing aphysical parameter of the patient, such as a pressure in the patient'sbody that relates to the pressure in the blood vessel may be provided,wherein the control device controls the stimulation device in responseto signals from the sensor. Such a sensor may for example sense thepressure in the patient's abdomen, the pressure against the implantedconstriction device or the pressure on the wall of the blood vessel.

In accordance with one flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the blood vessel is stopped. More precisely, thecontrol device may control the constriction device in a first mode toconstrict the constricted wall portion to stop the flow in the bloodvessel and in a second mode to cease the constriction of the wallportion to restore flow in the blood vessel. In this case, the controldevice only controls the stimulation device to stimulate the wallportion when needed. A sensor for sensing a physical parameter of thepatient's body that relates to the pressure in the blood vessel may beprovided, wherein the control device controls the stimulation device inresponse to signals from the sensor. Such a physical parameter may apressure in the patient's abdomen and the sensor may a pressure sensor.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the blood vessel in the constrictedstate. In this case, the control device is used when needed,conveniently by the patient, to control the stimulation device tostimulate the constricted wall of the blood vessel portion, preferablywhile adjusting the stimulation intensity, to cause contraction of thewall portion, such that the flow in the blood vessel is at least furtherrestricted or stopped, and to control the stimulation device to ceasethe stimulation. More precisely, the control device may:

a) control the stimulation device in a first mode to stimulate theconstricted wall portion to further restrict the flow in the bloodvessel, and control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the flow in the bloodvessel; or

b) control the stimulation device in a first mode to stimulate theconstricted wall portion to stop the flow in the blood vessel, andcontrol the stimulation device in a second mode to cease the stimulationof the wall portion to allow flow in the blood vessel.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions of the blood vessel, respectively. The control device maycontrol the constriction device to activate the constriction elements inrandom or in accordance with a predetermined sequence. In this case, thestimulation device includes stimulation elements positioned on theconstriction elements, wherein the control device controls thestimulation device to activate the stimulation elements to stimulate anywall portions of the series of wall portions constricted by theconstriction elements to contract the blood vessel to close the bloodvessel.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence toclose the blood vessel. The design of the constriction device in theform of a plurality of separate constriction elements makes possible tocounteract growth of hard fibrosis where the constriction device isimplanted.

Movement of Blood and/or Other Bodily Matter in Blood Vessels

The apparatus of the invention can be used for actively moving the bloodand/or other bodily matter in the blood vessels of a patient, asdescribed in the embodiments of the invention listed below.

1) The control device controls the constriction device to close theblood vessel, either at an upstream end or a downstream end of the wallportion, and then controls the constriction device to constrict theremaining part of the wall portion to move the blood and/or other bodilymatter in the blood vessel.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the flowin the blood vessel. The control device controls the stimulation deviceto stimulate the wall portion constricted by the constriction device toclose the blood vessel, either at an upstream end or a downstream end ofthe wall portion, and simultaneously controls the constriction device toincrease the constriction of the wall portion to move the blood and/orother bodily matter in the blood vessel.

2) The constriction device is adapted to constrict the wall portion torestrict or vary the flow in the blood vessel, and the control devicecontrols the stimulation device to progressively stimulate theconstricted wall portion, in the downstream or upstream direction of theblood vessel, to cause progressive contraction of the wall portion tomove the blood and/or other bodily matter in the blood vessels

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion, such that thewall portion is progressively constricted in the downstream or upstreamdirection of the blood vessel to move the blood and/or other bodilymatter in the blood vessel. The constriction device may include at leastone elongated constriction element that extends along the wall portion,wherein the control device controls the elongated constriction elementto progressively constrict the wall portion in the downstream orupstream direction of the blood vessel.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the blood vessel. Suitably, theelongated constriction element comprises contact surfaces dimensioned tocontact a length of the wall portion, when the constriction deviceconstricts the wall portion, and the stimulation device comprises aplurality of stimulation elements distributed along the contactsurfaces, such that the stimulation elements stimulate the differentareas of the wall portion along the length of the wall portion, when thecontrol device controls the stimulation device to stimulate the wallportion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions of the wall of the blood vessel to at least restrictthe flow in the blood vessel. The control device controls theconstriction device to successively constrict the wall portions of theseries of wall portions to move the blood and/or other bodily matter inthe blood vessel in a peristaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the wall of the blood vessel,respectively. The control device controls the constriction device toactivate the constriction elements one after the other, so that the wallportions of the series of well portions are successively constrictedalong the blood vessel, whereby the blood and/or other bodily matter inthe blood vessel is moved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the blood vessel to successively constrictthe wall portions of the series of wall portions, wherein the controldevice controls the constriction device to cyclically move theconstriction element along the wall portions of the series of wallportions. Preferably, the constriction device comprises a plurality ofconstriction elements, each of which is moveable along the wall of theblood vessel to successively constrict the wall portions of the seriesof wall portions, wherein the control device controls the constrictiondevice to cyclically move the constriction elements one after the otheralong the wall portions of the series of wall portions. Specifically,the constriction device includes a rotor carrying the constrictionelements, and the control device controls the rotor to rotate, such thateach constriction element cyclically constricts the wall portions of theseries of wall portions. Each constriction element suitably comprises aroller for rolling on the wall of the blood vessel to constrict thelatter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the blood vessel. Where the constriction deviceincludes at least one constriction element, the stimulation devicesuitably includes at least one stimulation element positioned on theconstriction element for stimulating the wall portion constricted by theconstriction element to close the blood vessel.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the bloodvessel.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the wall of the blood vessel to restrict the flow inthe blood vessel, wherein the constriction device includes a pluralityof constriction elements adapted to constrict the wall portions of thewall of the blood vessel, respectively, and the stimulation deviceincludes stimulation elements positioned on the constriction elementsfor stimulating the wall portions constricted by the constrictionelements to close the blood vessel. The control device controls theconstriction device to activate the constriction elements to constrictthe wall portions of the series of wall portions without completelyclosing the blood vessel, and controls the stimulation device toactivate the stimulation elements to stimulate the wall portions oneafter the other, so that the wall portions of the series of wallportions are successively contracted along the blood vessel to move theblood and/or other bodily matter in the blood vessel of the patient.

6) The constriction device comprises a first constriction element forconstricting the wall portion at an upstream end thereof, a secondconstriction element for constricting the wall portion at a downstreamend thereof, and a third constriction element for constricting the wallportion between the upstream and downstream ends thereof. The controldevice controls the first, second and third constriction elements toconstrict and release the wall portion independently of one another.More specifically, the control device controls the first or secondconstriction element to constrict the wall portion at the upstream ordownstream end thereof to close the blood vessel, and controls the thirdconstriction element to constrict the wall portion between the upstreamand downstream ends thereof, whereby the blood and/or other bodilymatter contained in the wall portion between the upstream and downstreamends thereof is moved downstream or upstream in the blood vessel.Optionally, the control device controls the stimulation device tostimulate the wall portion between the upstream and downstream endsthereof, when the third constriction element constricts the wallportion.

-   -   6a) In accordance with a first alternative, the control device        controls the first constriction element to constrict the wall        portion at the upstream end thereof to restrict the flow in the        blood vessel and controls the stimulation device to stimulate        the constricted wall portion at the upstream end to close the        blood vessel. With the blood vessel closed at the upstream end        of the constricted wall portion, the control device controls the        third constriction element to constrict the wall portion between        the upstream and downstream ends thereof, and optionally        controls the stimulation device to simultaneously stimulate the        wall portion as the latter is constricted by the third        constriction element. As a result, the blood and/or other bodily        matter contained in the wall portion between the upstream and        downstream ends thereof is moved downstream in the blood vessel.    -   6b) In accordance with a second alternative, the control device        controls the second constriction element to constrict the wall        portion at the downstream end thereof to restrict the flow in        the blood vessel and controls the stimulation device to        stimulate the constricted wall portion at the downstream end to        close the blood vessel. With the blood vessel closed at the        downstream end of the constricted wall portion, the control        device controls the third constriction element to constrict the        wall portion between the upstream and downstream ends thereof,        and optionally controls the stimulation device to simultaneously        stimulate the wall portion as the latter is constricted by the        third constriction element. As a result, the blood and/or other        bodily matter contained in the wall portion between the upstream        and downstream ends thereof is moved upstream in the blood        vessel.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion with electric pulses.

A particularly long wall portion of the blood vessel may be surgicallyprepared to extend in zigzag with adjacent walls stitched together bytwo parallel rows of stitches and with the adjacent walls cut throughbetween the two rows of stitches. As a result, the blood vessel of thislong wall portion of the blood vessel can be significantly expanded. Inthis case, the constriction device of the apparatus of the invention isable to move a considerably larger volume of blood each time itconstricts the long wall portion of the blood vessel.

The various solutions described above under the headline: “Flowrestriction” to stop the flow in the blood vessel may also be used inany of the above noted embodiments (1a), (1b), (4a), (5), (6), (6a) and(6b).

Stimulation

When stimulating tissue there is a risk of injuring or deteriorating thetissue over time, if the stimulation is not properly performed. Theapparatus of the present invention is designed to reduce or eveneliminate that risk. Thus, in accordance with the present invention, thecontrol device controls the stimulation device to intermittentlystimulate different areas of the wall portion of the blood vessel, suchthat at least two of the areas are stimulated at different points oftime that is, the stimulation is shifted from one area to another areaover time. In addition, the control device controls the stimulationdevice, such that an area of the different areas that currently is notstimulated has time to restore substantially normal blood circulationbefore the stimulation device stimulates the area again. Furthermore,the control device controls the stimulation device to stimulate eacharea during successive time periods, wherein each time period is shortenough to maintain satisfactory blood circulation in the area until thelapse of the time period. This gives the advantage that the apparatus ofthe present invention enables continuous stimulation of the wall portionof the blood vessel to achieve the desired flow control, whileessentially maintaining over time the natural physical properties of theblood vessel without risking injuring the blood vessel.

Also, by physically changing the places of stimulation on the bloodvessel over time as described above it is possible to create anadvantageous changing stimulation pattern on the blood vessel, in orderto achieve a desired flow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the wall of the blood vessel during the stimulation thereof,the control device may control the stimulation device to, preferablycyclically, vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area isstimulated with the first pulse train, while the second area is notstimulated with said second pulse train, and vice versa. Alternatively,the first and second pulse trains are shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the wall of the blood vessel portion of thepatient's blood vessel, preferably with electric pulses. In thisembodiment, the control device controls the stimulation device tostimulate the wall portion with electric pulses preferably in the formof electric pulse trains, when the wall portion is in the constrictedstate, to cause contraction of the wall portion. Of course, theconfiguration of the electric pulse trains may be similar to the abovedescribed pulse trains and the control device may control thestimulation device to electrically stimulate the different areas of thewall of the blood vessel in the same manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements are placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe wall of the blood vessel, such that the elongate pattern ofelectrical elements extends lengthwise along the wall of the bloodvessel, and the elements abut the respective areas of the wall portion.The elongate pattern of electrical elements may include one or more rowsof electrical elements extending lengthwise along the wall of the bloodvessel. Each row of electrical elements may form a straight, helical orzig-zag path of electrical elements, or any form of path. The controldevice may control the stimulation device to successively energize theelectrical elements longitudinally along the elongate pattern ofelectrical elements in a direction opposite to, or in the same directionas that of the flow in the patient's blood vessel.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the bloodvessel is to be kept closed for a relatively long time, the controldevice may control the stimulation device to energize the electricalelements, such that energized electrical elements form two waves ofenergized electrical elements that simultaneously advance from thecenter of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements. Suchwaves of energized electrical elements can be repeated over and overagain without harming the blood vessel and without moving blood or gasin any direction in the blood vessel.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's blood vessels. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's blood vessel, preferably substantially transverseto the flow direction in the blood vessel. In a third alternative, theelements of the group of energized electrical elements may form morethan two paths of energized electrical elements extending on differentsides of the patient's blood vessel, preferably substantially transverseto the flow direction in the patient's blood vessel.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's bloodvessel in the flow direction in the patient's blood vessel. Theelectrical elements of each group of electrical elements may form a pathof elements extending at least in part around the patient's bloodvessel. In a first alternative, the electrical elements of each group ofelectrical elements may form more than two paths of elements extendingon different sides of the patient's blood vessel, preferablysubstantially transverse to the flow direction in the patient's bloodvessel. The control device may control the stimulation device toenergize the groups of electrical elements in the series of groups inrandom, or in accordance with a predetermined pattern. Alternatively,the control device may control the stimulation device to successivelyenergize the groups of electrical elements in the series of groups in adirection opposite to, or in the same direction as that of, the flow inthe patient's blood vessel, or in both said directions starting from aposition substantially at the center of the constricted wall portion.For example, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's blood vessel such that theelongate pattern of electrical elements extends along the blood vesselin the same direction as that of the flow in the patient's blood vesseland the elements abut the respective areas of the wall portion of theblood vessel.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the blood vessel. Thus, the controldevice may control the stimulation device to cool the wall portion, whenthe wall portion is constricted, to cause contraction of the wallportion. For example, the constriction device may constrict the wallportion to at least restrict the flow in the blood vessel, and thecontrol device may control the stimulation device to cool theconstricted wall portion to cause contraction thereof, such that theflow in the blood vessel is at least further restricted, or furtherrestricted but not stopped, or stopped. Alternatively, the controldevice may control the stimulation device to heat the wall portion, whenthe wall portion is constricted and contracted, to cause expansion ofthe wall portion. Where applicable, thermal stimulation may be practisedin any of the embodiments of the present invention, and the thermalstimulation may be controlled in response to various sensors, forexample strain, motion or pressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing blood vessel motion, i.e.natural contractions, such as stomach or intestinal contractions,pressure sensors for sensing pressure in the blood vessel, strainsensors for sensing strain of the blood vessel, flow sensors for sensingblood flow in the blood vessel, spectro-photometrical sensors,Ph-sensors for sensing acidity or alkalinity of the blood in the bloodvessel, oxygen-sensors sensors for sensing the oxygen content of theblood in the blood vessel, or sensors for sensing the distribution ofthe stimulation on the stimulated blood vessel. Any conceivable sensorsfor sensing any other kind of useful physical parameter is used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the patient's blood vessel, wherein the control device controls theconstriction device and/or stimulation device to change the constrictionof the blood vessel in response to the pressure sensor sensing apredetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor is provided for sensing as the physical parameter the orientationof the patient with respect to the horizontal. The position sensor maybe a biocompatible version of what is shown in U.S. Pat. Nos. 4,942,668and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the blood vessel in response to the position sensor sensing that thepatient has assumed a substantially horizontal orientation, i.e. thatthe patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the blood vessel inresponse to the time of day. For that purpose the control device mayinclude a clock mechanism for controlling the constriction device and/orstimulation device to change the constriction of the blood vessel toincrease or decrease the influence on the flow in the blood vesselduring different time periods of the day. In case a sensor of any of theabove-described types for sensing a physical or functional parameter isprovided, either the clock mechanism is used for controlling theconstriction device and/or stimulation device provided that theparameter sensed by the sensor does not override the clock mechanism, orthe sensor is used for controlling the constriction device and/orstimulation device provided that the clock mechanism does not overridethe sensor. Suitably, the control device produces an indication, such asa sound signal or displayed information, in response to signals from thesensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe Internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's blood vessel, and the constriction andstimulation devices form a constriction/stimulation unit. Preferably,the constriction and stimulation devices of the constriction/stimulationunit are integrated in a single piece suitable for implantation. Theconstriction device of the unit comprises contact surfaces dimensionedto contact a length of a patient's blood vessel, and the stimulationdevice of the unit comprises a plurality of stimulation elementsprovided on and distributed along the contact surfaces. When the controldevice controls the stimulation device to stimulate the wall portion,the stimulation elements stimulate different areas of the wall portionalong the length of the wall portion. The stimulation elementspreferably comprise electric elements, as described above, forstimulating the wall portion with electric pulses. However, in mostapplications of the present invention, other kinds of stimulations, suchas thermal stimulation, could be suitable to employ.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the blood vessel, and the operation deviceoperates the clamping elements to clamp the wall portion between theclamping elements to constrict the wall portion of the blood vessel.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the blood vessel, and the operation device operates the clampingelement to clamp the wall portion between the clamping element and thebone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of theblood vessel, and the operation device rotates the engagement elements,such that the engagement elements engage and constrict the wall portionof the blood vessel.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the blood vessel, and the operation device moves the clampingelements towards each other to clamp the wall portion of the bloodvessel between the clamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around theblood vessel, wherein the loop defines a constriction opening. Theoperation device operates the constriction member in the loop to changethe size of the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

7) The constriction device is adapted to bend the wall portion of theblood vessel to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict said length of the wall ofthe blood vessel portion of the patient's blood vessel. For thispurpose, the constriction device may include two or more of thedescribed constriction elements/members to be applied in a row alongsaid length of the wall portion, wherein said row extends in thedirection of flow in the blood vessel. Preferably, such constrictionelements/members are non-inflatable and mechanically operable oradjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the blood vessel assumes a size in theconstricted state that enables the stimulation device to contract thewall portion such that the flow in the blood vessel is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the wall ofthe patient's blood vessel, so that the blood vessel is constricted uponexpansion of the cavity and released upon contraction of the cavity.

Alternatively, the cavity is defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that the bloodvessel is constricted upon contraction of the bellows and released uponexpansion of the bellows. Thus, a relatively small addition of hydraulicfluid to the bellows causes a relatively large increase in theconstriction of the wall portion. Such a bellows may also be replaced bya suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

-   -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members are        operable by magnetic means, hydraulic means, or electric control        means.

2b) The apparatus comprises a fluid conduit between the pump and thecavity, wherein the reservoir forms part of the conduit. The conduit andpump are devoid of any non-return valve. The reservoir forms a fluidchamber with a variable volume, and the pump distributes fluid from thechamber to the cavity by a reduction in the volume of the chamber andwithdraws fluid from the cavity by an expansion of the volume of thechamber. The apparatus further comprises a motor for driving the pump,wherein the pump comprises a movable wall of the reservoir for changingthe volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means are operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the blood vessel upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the blood vesselupon operation of the first piston/cylinder mechanism. By operating thesecond piston/cylinder mechanism hydraulic fluid is distributed betweenthe two piston/cylinder mechanisms, so that the first piston/cylindermechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of theblood vessel. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth, and the hydraulic means may also includea pump and an implantable reservoir containing hydraulic fluid. The pumpdistributes hydraulic fluid from the reservoir to the chambers to movethe clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the Internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling a flow of blood and/or other bodily matter ina patient's blood vessel, wherein the apparatus comprises an implantableconstriction device for gently constricting a portion of the wall of theblood vessel to influence the flow in the blood vessel, a stimulationdevice for intermittently and individually stimulating different areasof the wall portion, as the constriction device constricts the wallportion, to cause contraction of the wall portion to further influencethe flow in the blood vessel, wherein the constriction and stimulationdevices form an operable constriction/stimulation unit, a source ofenergy, and a control device operable from outside the patient's body tocontrol the source of energy to release energy for use in connectionwith the operation of the constriction/stimulation unit. In a simpleform of the invention, the source of energy, such as a battery oraccumulator, is implantable in the patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferred, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpmay be powered by the energy of the second form. The constriction devicemay be operable to perform at least one reversible function and themotor may be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

The present invention also provides a method for using an apparatus asdescribed above to control a flow of blood and/or other bodily matter ina blood vessel, the method comprising providing a wireless remotecontrol adapted to control the constriction device and/or stimulationdevice from outside the patient's body, and operating the wirelessremote control by the patient, when the patient wants to influence theflow of blood and/or other bodily matter in the blood vessels.

Vascular Aneurysm

Another object of the present invention is to overcome or at leastreduce some of the problems associated with existing treatments ofaneurysm.

In accordance with this object of the present invention, there isprovided a vascular aneurysm treatment apparatus for treating a vascularaneurysm of a blood vessel in a human or mammal patient. The apparatuscomprises an implantable constriction device configured to gentlyconstrict at least one portion of the tissue wall of the blood vesselextending along the aneurysm to reduce the bulge of the blood vesselcaused by the aneurysm, a stimulation device for stimulating the wallportion of the blood vessel tissue wall, and a control device forcontrolling the stimulation device to stimulate the wall portion, as theconstriction device constricts the wall portion, to cause contraction ofthe wall portion to further reduce the bulge of the blood vessel andstrengthen the blood vessel tissue wall.

The present invention also provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stageinfluence on the aneurysm. Thus, the constriction device may gentlyconstrict the tissue wall by applying a relatively weak force againstthe wall portion, and the stimulation device may stimulate theconstricted wall portion to achieve the desired final influence on theaneurysm, as well as stabilizing, treating, and monitoring the conditionof the blood vessel. The phrase “gently constricting a portion of thetissue wall” is to be understood as constricting the wall portionwithout injuring the blood vessel tissue.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the blood vessel, e.g. a blood vessel, allows tissue ofthe wall portion to maintain normal condition during the operation ofthe apparatus of the invention.

For the treatment of aneurysms, it is particularly preferred that thedevice is capable of supporting and preferably also strenghtening theblood vessel. A combination of stimulation and constriction is appliedto stimulate the healing of the vessel, preferably resulting in thereduction or disappearence of the aneurysm.

For some patient's, there will be daily adjustments of the implantedconstriction device. Therefore, in a preferred embodiment of theinvention, the constriction device is adjustable to enable adjustment ofthe constriction of the wall portion as desired, wherein the controldevice controls the constriction device to adjust the constriction ofthe wall portion. The control device may control the constriction andstimulation devices independently of each other, and simultaneously.Optionally, the control device may control the stimulation device tostimulate, or to not stimulate the wall portion while the control devicecontrols the constriction device to change the constriction of the wallportion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow in the blood vessel is obtained, alternatively the desired supportor treatment of the vessel, e.g. in the case of an aneurysm.

The apparatus may further comprise a sensor configured to sense aphysical parameter of the patient that relates to the pressure in theblood vessel, and the control device may control the constriction deviceand/or stimulation device to adjust the constriction and/or contractionof the wall portion in response to signals from the sensor. The sensormay sense a physical parameter of the patient or functional parameter ofthe apparatus. For example, the control device may control thestimulation device to increase the intensity of the stimulation of thewall portion in response to a sensed pressure increase or reduction inthe blood vessel, such that the flow in the blood vessel is stopped, forexample in an acute situation, i.e. a rupture of the anaeurysm. Anysensor for sensing a physical parameter of the patient, such as apressure in the patient's body that relates to the pressure in the bloodvessel may be provided, wherein the control device controls thestimulation device in response to signals from the sensor. Such a sensormay for example sense the pressure in the patient's abdomen, thepressure against the implanted constriction device or the pressure onthe tissue wall of the bodily blood vessel.

In the stabilization, treatment and monitoring of the anaeurysm, it isconceived that a pressure sensor is provided to account for thevariations in pressure and thereby provide a more gentle andphysiological support and treatment. It is also conceived that a sensoris provided to follow the healing or worsening of the condition, as wellas for alerting when pathological changes occur, and preferably indicateany changes in that direction.

In a particular embodiment of a device for treating an aneurysm, thesensor is a pressure sensor capable of detecting a sudden reduction ofpressure indicative of a bursting aneurysm, where such sudden pressurereduction ellicits a signal to the apparatus, and the apparatus includesa function of stopping the blood flow in response to such a signal. Acomplete stop of the blood flow to a part of the body, e.g. the lowerlimbs in the case of an aneurysm on the Y-bifurcation extending to thelegs, is of course only an acute measure, preventing death from internalhaemorrhage.

In another embodiment of a device for treating and monitoring ananeurysm, the sensor is a sensor capable of detecting a change in aparameter indicative of a pathological change in the aneurysm, e.g. achange in pressure, temperature, conductivity, pH or other parameter,indicating a worsening condition or an imminent burst of the anaeurysm.

In the above embodiment, the device comprises, in addition to saidsensor, also a device for transmitting an alarm signal when the measuredvalue of the above parameter deviates for a set range or thresholdvalue.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions of the blood vessel's tissue wall, respectively. The controldevice may control the constriction device to activate the constrictionelements in random or in accordance with a predetermined sequence. Inthis case, the stimulation device includes stimulation elementspositioned on the constriction elements, wherein the control devicecontrols the stimulation device to activate the stimulation elements tostimulate any wall portions of the series of wall portions constrictedby said constriction elements to contract the blood vessel to support orstimulate the walls of a blood vessel, or in acute situations even closethe its blood vessel.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence. Thedesign of the constriction device in the form of a plurality of separateconstriction elements makes possible to counteract growth of hardfibrosis where the constriction device is implanted.

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of theblood vessel, such that at least two of the areas are stimulated atdifferent points of time that is, the stimulation is shifted from onearea to another area over time. In addition, the control device controlsthe stimulation device, such that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before the stimulation device stimulates the areaagain. Furthermore, the control device controls the stimulation deviceto stimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the blood vessel to achieve the desired flowcontrol, while essentially maintaining over time the natural physicalproperties of the blood vessel without risking injuring the bloodvessel.

Also, by physically changing the places of stimulation on the bloodvessel over time as described above it is possible to create anadvantageous changing stimulation pattern on the blood vessel, in orderto achieve a desired flow control and preferably a positive influence onthe health an regeneration of tissue.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall during the stimulation thereof, the controldevice may control the stimulation device to, preferably cyclically,vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with said second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue wall portion of the patient's bloodvessel, preferably with electric pulses. This embodiment is particularlysuited for applications in which the wall portion includes muscle fibersthat react to electrical stimula. In this embodiment, the control devicecontrols the stimulation device to stimulate the wall portion withelectric pulses preferably in the form of electric pulse trains, whenthe wall portion is in the constricted state, to cause contraction ofthe wall portion. Of course, the configuration of the electric pulsetrains may be similar to the above described pulse trains and thecontrol device may control the stimulation device to electricallystimulate the different areas of the wall of the blood vessel in thesame manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the blood vessel, such that the elongate patternof electrical elements extends lengthwise along the wall of the bloodvessel, and the elements abut the respective areas of the wall portion.The elongate pattern of electrical elements may include one or more rowsof electrical elements extending lengthwise along the wall of the bloodvessel. Each row of electrical elements may form a straight, helical orzig-zag path of electrical elements, or any form of path. The controldevice may control the stimulation device to successively energize theelectrical elements longitudinally along the elongate pattern ofelectrical elements in a direction opposite to, or in the same directionas that of, the flow in the blood vessel of a blood vessel.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the bloodvessel of the blood vessel, for example a blood vessel in the case of arupture, is to be kept closed for a relatively long time, the controldevice may control the stimulation device to energize the electricalelements, such that energized electrical elements form two waves ofenergized electrical elements that simultaneously advance from thecenter of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements. Suchwaves of energized electrical elements can be repeated over and overagain without harming the blood vessel and without moving fluid in anydirection in the blood vessel of the blood vessel.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's blood vessel. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's blood vessel, preferably substantially transverseto the flow direction in the blood vessel. In a third alternative, theelements of the group of energized electrical elements may form morethan two paths of energized electrical elements extending on differentsides of the patient's blood vessel, preferably substantially transverseto the flow direction.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the blood vessel in thedirection of flow. The electrical elements of each group of electricalelements may form a path of elements extending at least in part aroundthe patient's blood vessel. In a first alternative, the electricalelements of each group of electrical elements may form more than twopaths of elements extending on different sides of the blood vessel,preferably substantially transverse to the flow direction said vessel.The control device may control the stimulation device to energize thegroups of electrical elements in the series of groups in random, or inaccordance with a predetermined pattern. Alternatively, the controldevice may control the stimulation device to successively energize thegroups of electrical elements in the series of groups in a directionopposite to, or in the same direction as that of, the flow in the bloodvessel, or in both said directions starting from a positionsubstantially at the center of the constricted wall portion. Forexample, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's blood vessel such that theelongate pattern of electrical elements extends along the blood vesselin the same direction as that of the flow in blood vessel and theelements abut the respective areas of the wall portion of the bloodvessel.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the blood vessel. Thus, the controldevice may control the stimulation device to cool the wall portion, whenthe wall portion is constricted, to cause contraction of the wallportion. Alternatively, the control device may control the stimulationdevice to heat the wall portion, when the wall portion is constrictedand contracted, to cause expansion of the wall portion. The controldevice may control the stimulation device to cool the blood vessel tocause contraction thereof, or heat the blood vessel to cause expansionthereof. Where applicable, thermal stimulation may be practised in anyof the embodiments of the present invention, and the thermal stimulationmay be controlled in response to various sensors, for example strain,motion or pressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example pressure sensors for sensing pressure in the bloodvessel, strain sensors for sensing strain of the blood vessel, flowsensors for sensing fluid flow in the blood vessel of the blood vessel,spectro-photometrical sensors, Ph-sensors for sensing acidity oralkalinity of the fluid in the blood vessel of the blood vessel,oxygen-sensors sensors for sensing the oxygen content of the fluid inthe blood vessel or walls thereof, or sensors for sensing thedistribution of the stimulation on the stimulated blood vessel. Anyconceivable sensors for sensing any other kind of useful physicalparameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the blood vessel, wherein the control device controls theconstriction device and/or stimulation device to change the constrictionof the wall portion in response to the pressure sensor sensing apredetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of the wallportion during different time periods of the day. In case a sensor ofany of the above-described types for sensing a physical or functionalparameter is provided, either the dock mechanism is used for controllingthe constriction device and/or stimulation device provided that theparameter sensed by the sensor does not override the clock mechanism, orthe sensor is used for controlling the constriction device and/orstimulation device provided that the clock mechanism does not overridethe sensor. Suitably, the control device produces an Indication, such asa sound signal or displayed information, in response to signals from thesensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patients tissue wall portion, and the constrictionand stimulation devices form a constriction/stimulation unit.

Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of a tissue wall portion of apatient's blood vessel, and the stimulation device of the unit comprisesa plurality of stimulation elements provided on and distributed alongthe contact surfaces. When the control device controls the stimulationdevice to stimulate the wall portion, the stimulation elements stimulatedifferent areas of the wall portion along the length of the wallportion. The stimulation elements preferably comprise electric elements,as described above, for stimulating the wall portion with electricpulses. However, in most applications of the present invention, otherkinds of stimulations, such as thermal stimulation, could be suitable toemploy.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the blood vessel, and the operation deviceoperates the clamping elements to clamp the wall portion between theclamping elements to constrict the wall portion of the blood vessel.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the blood vessel, and the operation device operates the clampingelement to clamp the wall portion between the clamping element and thebone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of theblood vessel, and the operation device rotates the engagement elements,such that the engagement elements engage and constrict the wall portionof the blood vessel.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the blood vessel, and the operation device moves the clampingelements towards each other to clamp the wall portion of the bloodvessel between the clamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the constriction.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around theblood vessel, wherein the loop defines a constriction opening. Theoperation device operates the constriction member in the loop to changethe size of the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

In the above noted embodiments (1) to (6d), it is important that theconstriction device is designed to constrict said length of the tissuewall portion of the patient's blood vessel. For this purpose, theconstriction device may include two or more of the describedconstriction elements/members to be applied in a row along said lengthof the wall portion, wherein said row extends in the direction of flowin the blood vessel. Preferably, such constriction elements/members arenon-inflatable and mechanically operable or adjustable. An example of anon-inflatable constriction element is a cylinder, arranged around ablood vessel and supporting the same. Preferably said cylinder iselastic, and more preferably it is part of a device incorporating one ormore of the functions of constriction, stimulation and monitoringdescribed herein.

In the above noted embodiments (1) to (6d), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the aneurysm assumes a size in the constrictedstate that enables the stimulation device to contract the wall portionas desired, which may be a life-saving action in acute situations.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the tissuewall portion of the patient's blood vessel, so that the patient's wallportion is constricted upon expansion of the cavity and released uponcontraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

-   -   1) The reservoir comprises first and second wall portions, and        the operation device displaces the first and second wall        portions relative to each other to change the volume of the        reservoir, such that fluid is distributed from the reservoir to        the cavity, or from the cavity to the reservoir.    -   1a) The first and second wall portions of the reservoir are        displaceable relative to each other by at least one of a        magnetic device, a hydraulic device or an electric control        device.    -   2) The operation device comprises a pump for pumping fluid        between the reservoir and the cavity.    -   2a) The pump comprises a first activation member for activating        the pump to pump fluid from the reservoir to the cavity and a        second activation member for activating the pump to pump fluid        from the cavity to the reservoir.    -   2a1) The first and second activation members are operable by        manual manipulation thereof.    -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.    -   2a3) At least one of the first and second activating members is        operable by magnetic means, hydraulic means, or electric control        means.    -   2b) The apparatus comprises a fluid conduit between the pump and        the cavity, wherein the reservoir forms part of the conduit. The        conduit and pump are devoid of any non-return valve. The        reservoir forms a fluid chamber with a variable volume, and the        pump distributes fluid from the chamber to the cavity by a        reduction in the volume of the chamber and withdraws fluid from        the cavity by an expansion of the volume of the chamber. The        apparatus further comprises a motor for driving the pump,        wherein the pump comprises a movable wall of the reservoir for        changing the volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of theblood vessel. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth. Further, the hydraulic means may alsoinclude a pump and an implantable reservoir containing hydraulic fluid.The pump distributes hydraulic fluid from the reservoir to the chambersto move the clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for treating a vascular aneurysm of a blood vessel, supportingthe walls thereof, and stimulating the walls, wherein the apparatuscomprises an implantable constriction device for gently constricting aportion of the tissue wall, a stimulation device for intermittently andindividually stimulating different areas of the wall portion, as theconstriction device constricts the wall portion, to cause contraction ofthe wall portion to further strengthen the blood vessel, wherein theconstriction and stimulation devices form an operableconstriction/stimulation unit, a source of energy, and a control deviceoperable from outside the patient's body to control the source of energyto release energy for use in connection with the operation of theconstriction/stimulation unit. In a simple form of the invention, thesource of energy, such as a battery or accumulator, is implantable inthe patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theInternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

The present invention also provides a method for using an apparatus asdescribed above to treat a vascular aneurysm of a blood vessel in ahuman or mammal patient, the method comprising providing a wirelessremote control adapted to control at least one of the constriction andstimulation devices from outside the patient's body, and operating thewireless remote control by the patient, when the patient wants to changethe influence on the aneurysm.

The present invention also provides a method for treating a vascularaneurysm of a blood vessel in a human or mammal patient, the methodcomprising: gently constricting a portion of the tissue wall of theblood vessel extending along the aneurysm to reduce the bulge of theblood vessel caused by the aneurysm, and stimulating the constrictedwall portion of the blood vessel tissue wall to cause contraction of thewall portion to further reduce the bulge of the blood vessel andstrengthen the blood vessel tissue.

Male Contraception

Another object of the present invention is to provide an apparatus thatprovides more safety and convenience with male contraception based onocclusion of vas deference.

In accordance with this object of the present invention, there isprovided a male contraception apparatus for obtaining a time-limitedsterility of a male mammalian individual comprising a flow influencedevice configured to influence a flow of sperms appearing in the lumenof a vas deference of a male patient, and a control device operable tocontrol the flow influence device to influence the flow of sperms in thevas deference. The term “vas deference” may include one vas deference orboth vase deferentia.

In an embodiment of the invention, the flow influence device comprisesan implantable constriction device configured to constrict at least oneportion of the vas deference wall, and the control device is operable tocontrol the constriction device to constrict the uterine tube wallportion to influence the flow of sperms in the lumen of the vasdeference. Specifically, the constriction device is configured toconstrict the vas deference to restrict the flow of sperms therein, andthe control device is operable to control the constriction device toconstrict the vas deference such that the flow of sperms in the vasdeference is stopped, and to control the constriction device to releasethe vas deference such that the sperms appearing in the uterine tube areallowed to flow in the uterine tube.

In another embodiment of the invention, the constriction device isconfigured to gently constrict the vas deference wall portion toinfluence the flow of sperms in the lumen of the vas deference, the flowinfluence device comprises an implantable stimulation device configuredto stimulate the vas deference wall portion, and the control device isoperable to control the stimulation device to stimulate the vasdeference wall portion, as the constriction device constricts the vasdeference wall portion, to cause contraction of the vas deference wallportion to further influence the flow of sperms in the vas deference.Specifically, the constriction device is configured to gently constrictthe vas deference wall portion to restrict the flow of sperms in the vasdeference, and the control device is operable to control the stimulationdevice to stimulate the vas deference wall portion, as the constrictiondevice constricts the vas deference wall portion, to cause contractionof the vas deference wall portion to further restrict the flow of spermsin the vas deference.

As a result, the present invention provides an advantageous combinationof constriction and stimulation devices, which results in a two-stageinfluence on the vas deference. Thus, the constriction device may gentlyconstrict the tissue wall by applying a relatively weak force againstthe wall portion, and the stimulation device may stimulate theconstricted wall portion to achieve the desired final influence on theflow in this lumen. The phrase “gently constricting a portion of thetissue wall” is to be understood as constricting the wall portionwithout substantially hampering the blood circulation in the tissuewall.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the vas deference allows tissue of the wall portion tomaintain substantially normal blood circulation during the operation ofthe apparatus of the invention.

In certain embodiments of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionas desired, wherein the control device controls the constriction deviceto adjust the constriction of the wall portion. The control device maycontrol the constriction and stimulation devices independently of eachother, and simultaneously. Optionally, the control device may controlthe stimulation device to stimulate, or to not stimulate the wallportion while the control device controls the constriction device tochange the constriction of the wall portion.

Additionally, the apparatus according to the present invention comprisesembodiments wherein the transpiration flow of sperms is controlled byadapting the performance constriction and stimulation device fortransportation, rather than restriction.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the wall portion until the desired restriction of theflow in the lumen is obtained.

Flow Restriction

The apparatus of the present invention is well suited for restrictingthe flow of fluids in the lumen of a vas deference. Thus, in a principalembodiment of the invention, the constriction device is adapted toconstrict the wall portion to at least restrict the flow in the lumen,and the control device controls the stimulation device to causecontraction of the constricted wall portion, so that the flow in thelumen is at least further restricted. Specifically, the constrictiondevice is adapted to constrict the wall portion to a constricted statein which the blood circulation in the constricted wall portion issubstantially unrestricted and the flow in the lumen is at leastrestricted, and the control device controls the stimulation device tocause contraction of the wall portion, so that the flow in the lumen isat least further restricted when the wall portion is kept by theconstriction device in the constricted state.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the wall portion, such that flow in the lumen is restrictedbut not stopped, and controls the stimulation device to stimulate theconstricted wall portion to cause contraction thereof, such that flow inthe lumen is further restricted but not stopped. More precisely, thecontrol device may control the stimulation device in a first mode tostimulate the constricted wall portion to further restrict but not stopthe flow in the lumen and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to increase the flow in the        lumen; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the flow in the lumen.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat flow in the lumen is restricted but not stopped, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that flow in the lumen is stopped. Moreprecisely, the control device may control the stimulation device in afirst mode to stimulate the constricted wall portion to further restrictbut not stop the flow in the lumen and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to allow flow in the lumen; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the flow in the lumen.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the lumen is substantially stopped, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that the flow in the lumen is completelystopped. More precisely, the control device may control the stimulationdevice in a first mode to stimulate the constricted wall portion tocompletely stop the flow in the lumen and to:

-   -   a) control the stimulation device in a second mode to cease the        stimulation of the wall portion to allow flow in the lumen; or    -   b) control the stimulation and constriction devices in the        second mode to cease the stimulation of the wall portion and        release the wall portion to restore the flow in the lumen.

Since the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion,the risk of the implanted constriction device injuring the vas deferenceover time is significantly reduced or even eliminated, and it is insuredthat the effect of the stimulation is maintained over time.

Where the stimulation device stimulates the constricted wall portion tocontract, such that the flow in the lumen is stopped, the control devicesuitably controls the stimulation device to simultaneously andcyclically stimulate a first length of the constricted wall portion anda second length of the constricted wall portion, which is locateddownstream of the first length, wherein the control device controls thestimulation device to progressively stimulate the first length in theupstream direction of the lumen and to progressively stimulate thesecond length in the downstream direction of the lumen.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the lumen, such that the flowin the lumen remains stopped. Any sensor for sensing a physicalparameter of the patient, such as a pressure in the patient's body thatrelates to the pressure in the lumen may be provided, wherein thecontrol device controls the stimulation device in response to signalsfrom the sensor. Such a sensor may for example sense the pressure in thepatient's abdomen, the pressure against the implanted constrictiondevice or the pressure on the tissue wall of the bodily vas deference.

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the flow in the lumen is stopped. More precisely, the controldevice may control the constriction device in a first mode to constrictthe constricted wall portion to stop the flow in the lumen and in asecond mode to cease the constriction of the wall portion to restoreflow in the lumen. In this case, the control device only controls thestimulation device to stimulate the wall portion when needed. A sensorfor sensing a physical parameter of the patient's body that relates tothe pressure in the lumen may be provided, wherein the control devicecontrols the stimulation device in response to signals from the sensor.Such a physical parameter may be a pressure in the patient's abdomen andthe sensor may be a pressure sensor.

For some patient's, the implanted constriction device may be designed tonormally keep the patient's wall portion of the vas deference in theconstricted state. In this case, the control device may be used whenneeded, conveniently by the patient, to control the stimulation deviceto stimulate the constricted tissue wall portion, preferably whileadjusting the stimulation intensity, to cause contraction of the wallportion, such that the flow in the lumen is at least further restrictedor stopped, and to control the stimulation device to cease thestimulation. More precisely, the control device may:

-   -   a) control the stimulation device in a first mode to stimulate        the constricted wall portion to further restrict the flow in the        lumen, and control the stimulation device in a second mode to        cease the stimulation of the wall portion to increase the flow        in the lumen; or    -   b) control the stimulation device in a first mode to stimulate        the constricted wall portion to stop the flow in the lumen, and        control the stimulation device in a second mode to cease the        stimulation of the wall portion to allow flow in the lumen.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions of the vas deference's tissue wall, respectively. The controldevice may control the constriction device to activate the constrictionelements in random or in accordance with a predetermined sequence. Inthis case, the stimulation device includes stimulation elementspositioned on the constriction elements, wherein the control devicecontrols the stimulation device to activate the stimulation elements tostimulate any wall portions of the series of wall portions constrictedby said constriction elements to contract the vas deference to close thevas deference's lumen.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence toclose the vas deference's lumen. The design of the constriction devicein the form of a plurality of separate constriction elements makespossible to counteract growth of hard fibrosis where the constrictiondevice is implanted.

Movement of Fluid in Lumen

The apparatus of the invention can be used for actively moving the fluidin the lumen of a patient's vas deference, as described in theembodiments of the invention listed below.

1) The control device controls the constriction device to close thelumen, either at an upstream end or a downstream end of the wallportion, and then controls the constriction device to constrict theremaining part of the wall portion to move the fluid in the lumen.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the flowin the lumen. The control device controls the stimulation device tostimulate the wall portion constricted by the constriction device toclose the lumen, either at an upstream end or a downstream end of thewall portion, and simultaneously controls the constriction device toincrease the constriction of the wall portion to move the fluid in thelumen.

2) The constriction device is adapted to constrict the wall portion torestrict or vary the flow in the lumen, and the control device controlsthe stimulation device to progressively stimulate the constricted wallportion, in the downstream or upstream direction of the lumen, to causeprogressive contraction of the wall portion to move the fluid in thelumen.

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion, such that thewall portion is progressively constricted in the downstream or upstreamdirection of the lumen to move the fluid in the lumen. The constrictiondevice may include at least one elongated constriction element thatextends along the wall portion, wherein the control device controls theelongated constriction element to progressively constrict the wallportion in the downstream or upstream direction of the lumen.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the lumen. Suitably, the elongatedconstriction element comprises contact surfaces dimensioned to contact alength of the wall portion, when the constriction device constricts thewall portion, and the stimulation device comprises a plurality ofstimulation elements distributed along the contact surfaces, such thatthe stimulation elements stimulate the different areas of the wallportion along the length of the wall portion, when the control devicecontrols the stimulation device to stimulate the wall portion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to at least restrict the flow in thelumen. The control device controls the constriction device tosuccessively constrict the wall portions of the series of wall portionsto move the fluid in the lumen in a peristaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the tissue wall, respectively.The control device controls the constriction device to activate theconstriction elements one after the other, so that the wall portions ofthe series of wall portions are successively constricted along the vasdeference, whereby the fluid in the lumen is moved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the vas deference to successively constrictthe wall portions of the series of wall portions, wherein the controldevice controls the constriction device to cyclically move theconstriction element along the wall portions of the series of wallportions. Preferably, the constriction device comprises a plurality ofconstriction elements, each of which is moveable along the wall of thevas deference to successively constrict the wall portions of the seriesof wall portions, wherein the control device controls the constrictiondevice to cyclically move the constriction elements one after the otheralong the wall portions of the series of wall portions. Specifically,the constriction device includes a rotor carrying the constrictionelements, and the control device controls the rotor to rotate, such thateach constriction element cyclically constricts the wall portions of theseries of wall portions. Each constriction element suitably comprises aroller for rolling on the wall of the vas deference to constrict thelatter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the lumen. Where the constriction device includes atleast one constriction element, the stimulation device suitably includesat least one stimulation element positioned on the constriction elementfor stimulating the wall portion constricted by the constriction elementto close the lumen.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the lumen.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to restrict the flow in the lumen,wherein the constriction device includes a plurality of constrictionelements adapted to constrict the wall portions of the tissue wall,respectively, and the stimulation device includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the lumen.The control device controls the constriction device to activate theconstriction elements to constrict the wall portions of the series ofwall portions without completely closing the vas deference's lumen, andcontrols the stimulation device to activate the stimulation elements tostimulate the wall portions one after the other, so that the wallportions of the series of wall portions are successively contractedalong the vas deference to move the fluid in the lumen of the patient'svas deference.

6) The constriction device comprises a first constriction element forconstricting the wall portion at an upstream end thereof, a secondconstriction element for constricting the wall portion at a downstreamend thereof, and a third constriction element for constricting the wallportion between the upstream and downstream ends thereof. The controldevice controls the first, second and third constriction elements toconstrict and release the wall portion independently of one another.More specifically, the control device controls the first or secondconstriction element to constrict the wall portion at the upstream ordownstream end thereof to close the lumen, and controls the thirdconstriction element to constrict the wall portion between the upstreamand downstream ends thereof, whereby the fluid contained in the wallportion between the upstream and downstream ends thereof is moveddownstream or upstream in the lumen. Optionally, the control devicecontrols the stimulation device to stimulate the wall portion betweenthe upstream and downstream ends thereof, when the third constrictionelement constricts the wall portion.

-   -   6a) In accordance with a first alternative, the control device        controls the first constriction element to constrict the wall        portion at the upstream end thereof to restrict the flow in the        lumen and controls the stimulation device to stimulate the        constricted wall portion at the upstream end to close the lumen.        With the lumen closed at the upstream end of the constricted        wall portion, the control device controls the third constriction        element to constrict the wall portion between the upstream and        downstream ends thereof, and optionally controls the stimulation        device to simultaneously stimulate the wall portion as the        latter is constricted by the third constriction element. As a        result, the fluid contained in the wall portion between the        upstream and downstream ends thereof is moved downstream in the        lumen.    -   6b) In accordance with a second alternative, the control device        controls the second constriction element to constrict the wall        portion at the downstream end thereof to restrict the flow in        the lumen and controls the stimulation device to stimulate the        constricted wall portion at the downstream end to close the        lumen. With the lumen closed at the downstream end of the        constricted wall portion, the control device controls the third        constriction element to constrict the wall portion between the        upstream and downstream ends thereof, and optionally controls        the stimulation device to simultaneously stimulate the wall        portion as the latter is constricted by the third constriction        element. As a result, the fluid contained in the wall portion        between the upstream and downstream ends thereof is moved        upstream in the lumen.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion with electric pulses.

Where the vas deference is tubular in shape, such as the smallintestines, a particularly long wall portion of the tubular vasdeference may be surgically prepared to extend in zigzag with adjacentwalls stitched together by two parallel rows of stitches and with theadjacent walls cut through between the two rows of stitches. As aresult, the lumen of this long wall portion of the vas deference can besignificantly expanded. In this case, the constriction device of theapparatus of the invention is able to move a considerably larger volumeof fluid each time it constricts the long wall portion of the vasdeference.

The various solutions described above under the headline: “Flowrestriction” to stop the flow in the lumen of the vas deference may alsobe used in any of the above noted embodiments (1a), (1b), (4a), (5),(6), (6a) and (6b).

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of the vasdeference, such that at least two of the areas are stimulated atdifferent points of time that is, the stimulation is shifted from onearea to another area over time. In addition, the control device controlsthe stimulation device, such that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before the stimulation device stimulates the areaagain. Furthermore, the control device controls the stimulation deviceto stimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the vas deference to achieve the desired flowcontrol, while essentially maintaining over time the natural physicalproperties of the vas deference without risking injuring the vasdeference.

Also, by physically changing the places of stimulation on the vasdeference over time as described above it is possible to create anadvantageous changing stimulation pattern on the vas deference, in orderto achieve a desired flow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall during the stimulation thereof, the controldevice may control the stimulation device to, preferably cyclically,vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with said second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue wall portion of the patient's bodilyvas deference, preferably with electric pulses. This embodiment isparticularly suited for applications in which the wall portion includesmuscle fibers that react to electrical stimula. In this embodiment, thecontrol device controls the stimulation device to stimulate the wallportion with electric pulses preferably in the form of electric pulsetrains, when the wall portion is in the constricted state, to causecontraction of the wall portion. Of course, the configuration of theelectric pulse trains may be similar to the above described pulse trainsand the control device may control the stimulation device toelectrically stimulate the different areas of the wall of the vasdeference in the same manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the wall portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the vas deference, such that the elongate patternof electrical elements extends lengthwise along the wall of the vasdeference, and the elements abut the respective areas of the wallportion. The elongate pattern of electrical elements may include one ormore rows of electrical elements extending lengthwise along the wall ofthe vas deference. Each row of electrical elements may form a straight,helical or zig-zag path of electrical elements, or any form of path. Thecontrol device may control the stimulation device to successivelyenergize the electrical elements longitudinally along the elongatepattern of electrical elements in a direction opposite to, or in thesame direction as that of, the flow in the patient's lumen.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the lumen ofthe vas deference is to be kept closed for a relatively long time, thecontrol device may control the stimulation device to energize theelectrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements. Suchwaves of energized electrical elements can be repeated over and overagain without harming the vas deference and without moving fluid or gasin any direction in the lumen of the vas deference.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's vas deference. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's vas deference, preferably substantiallytransverse to the flow direction in the lumen of the vas deference. In athird alternative, the elements of the group of energized electricalelements may form more than two paths of energized electrical elementsextending on different sides of the patient's vas deference, preferablysubstantially transverse to the flow direction in the patient's lumen.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the patient's vasdeference in the flow direction in the patient's lumen. The electricalelements of each group of electrical elements may form a path ofelements extending at least in part around the patient's vas deference.In a first alternative, the electrical elements of each group ofelectrical elements may form more than two paths of elements extendingon different sides of the patient's vas deference, preferablysubstantially transverse to the flow direction in the patient's lumen.The control device may control the stimulation device to energize thegroups of electrical elements in the series of groups in random, or inaccordance with a predetermined pattern. Alternatively, the controldevice may control the stimulation device to successively energize thegroups of electrical elements in the series of groups in a directionopposite to, or in the same direction as that of, the flow in thepatient's lumen, or in both said directions starting from a positionsubstantially at the center of the constricted wall portion. Forexample, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's vas deference such that theelongate pattern of electrical elements extends along the vas deferencein the same direction as that of the flow in the patient's lumen and theelements abut the respective areas of the wall portion of the vasdeference.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the vas deference. Thus, the controldevice may control the stimulation device to cool the wall portion, whenthe wall portion is constricted, to cause contraction of the wallportion. For example, the constriction device may constrict the wallportion to at least restrict the flow in the lumen, and the controldevice may control the stimulation device to cool the constricted wallportion to cause contraction thereof, such that the flow in the lumen isat least further restricted, or further restricted but not stopped, orstopped. Alternatively, the control device may control the stimulationdevice to heat the wall portion, when the wall portion is constrictedand contracted, to cause expansion of the wall portion. Where the wallportion includes a blood vessel, the control device may control thestimulation device to cool the blood vessel to cause contractionthereof, or heat the blood vessel to cause expansion thereof. Whereapplicable, thermal stimulation may be practised in any of theembodiments of the present invention, and the thermal stimulation may becontrolled in response to various sensors, for example strain, motion orpressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing vas deference motion, i.e.natural contractions, such as stomach or intestinal contractions,pressure sensors for sensing pressure in the vas deference, strainsensors for sensing strain of the vas deference, flow sensors forsensing fluid flow in the lumen of the vas deference,spectro-photometrical sensors, Ph-sensors for sensing acidity oralkalinity of the fluid in the lumen of the vas deference,oxygen-sensors sensors for sensing the oxygen content of the fluid inthe lumen of the vas deference, or sensors for sensing the distributionof the stimulation on the stimulated vas deference. Any conceivablesensors for sensing any other kind of useful physical parameter may beused.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the lumen of the patient's bodily vas deference, wherein the controldevice controls the constriction device and/or stimulation device tochange the constriction of the patient's wall portion in response to thepressure sensor sensing a predetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's wall portion to increase or decrease the influence on the flowin the lumen during different time periods of the day. In case a sensorof any of the above-described types for sensing a physical or functionalparameter is provided, either the clock mechanism is used forcontrolling the constriction device and/or stimulation device providedthat the parameter sensed by the sensor does not override the clockmechanism, or the sensor is used for controlling the constriction deviceand/or stimulation device provided that the clock mechanism does notoverride the sensor. Suitably, the control device produces anindication, such as a sound signal or displayed information, in responseto signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichis settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned clock mechanism, wherein the wireless remote controlalso is adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's tissue wall portion, and the constrictionand stimulation devices form a constriction/stimulation unit.Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of a tissue wall portion of apatient's vas deference, and the stimulation device of the unitcomprises a plurality of stimulation elements provided on anddistributed along the contact surfaces. When the control device controlsthe stimulation device to stimulate the wall portion, the stimulationelements stimulate different areas of the wall portion along the lengthof the wall portion. The stimulation elements preferably compriseelectric elements, as described above, for stimulating the wall portionwith electric pulses. However, in most applications of the presentinvention, other kinds of stimulations, such as thermal stimulation,could be suitable to employ.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments.

1) The constriction device comprises at least two elongated clampingelements having the contact surfaces and extending along the wallportion on different sides of the vas deference, and the operationdevice operates the clamping elements to clamp the wall portion betweenthe clamping elements to constrict the wall portion of the vasdeference.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the vas deference, and the operation device operates theclamping element to clamp the wall portion between the clamping elementand the bone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of the vasdeference, and the operation device rotates the engagement elements,such that the engagement elements engage and constrict the wall portionof the vas deference.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the vas deference, and the operation device moves the clampingelements towards each other to clamp the wall portion of the vasdeference between the clamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around thevas deference, wherein the loop defines a constriction opening. Theoperation device operates the constriction member in the loop to changethe size of the constriction opening.

-   -   6a) The elongated constriction member comprises a belt having        the contact surfaces, and the operation device operates the belt        to change the longitudinal extension of the belt in the loop to        change the size of the constriction opening. The forming means        may form the constriction member or belt into a loop having at        least one predetermined size.    -   6b) The elongated constriction member is operable to change the        size of the constriction opening, such that the outer        circumferential confinement surface of the constriction device        is changed, or, alternatively, is unchanged.    -   6c) The elongated constriction member is elastic and varies in        thickness as seen in a cross-section there through, and is        operable to turn around the longitudinal extension of the        constriction member.    -   6d) The elongated constriction member comprises two        substantially or partly semi-circular frame elements having the        contact surfaces and hinged together, such that the        semi-circular elements are swingable relative to each other from        a fully open state in which they substantially or partly form a        circle to a fully folded state in which they substantially form        a semi-circle.

7) The constriction device is adapted to bend the wall portion of thevas deference to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict said length of the tissuewall portion of the patient's vas deference. For this purpose, theconstriction device may include two or more of the describedconstriction elements/members to be applied in a row along said lengthof the wall portion, wherein said row extends in the direction of flowin the lumen of the vas deference. Preferably, such constrictionelements/members are non-inflatable and mechanically operable oradjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the lumen assumes a size in the constrictedstate that enables the stimulation device to contract the wall portionsuch that the flow in the lumen is stopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the tissuewall portion of the patient's vas deference, so that the patient's wallportion is constricted upon expansion of the cavity and released uponcontraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

-   -   1a) The first and second wall portions of the reservoir are        displaceable relative to each other by at least one of a        magnetic device, a hydraulic device or an electric control        device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

-   -   2a) The pump comprises a first activation member for activating        the pump to pump fluid from the reservoir to the cavity and a        second activation member for activating the pump to pump fluid        from the cavity to the reservoir.        -   2a1) The first and second activation members are operable by            manual manipulation thereof.        -   2a2) At least one of the activation members operates when            subjected to an external predetermined pressure.        -   2a3) At least one of the first and second activating members            is operable by magnetic means, hydraulic means, or electric            control means.    -   2b) The apparatus comprises a fluid conduit between the pump and        the cavity, wherein the reservoir forms part of the conduit. The        conduit and pump are devoid of any non-return valve. The        reservoir forms a fluid chamber with a variable volume, and the        pump distributes fluid from the chamber to the cavity by a        reduction in the volume of the chamber and withdraws fluid from        the cavity by an expansion of the volume of the chamber. The        apparatus further comprises a motor for driving the pump,        wherein the pump comprises a movable wall of the reservoir for        changing the volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of thevas deference. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth, and the hydraulic means may also includea pump and an implantable reservoir containing hydraulic fluid. The pumpdistributes hydraulic fluid from the reservoir to the chambers to movethe clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling a flow of fluid in a lumen formed by a tissuewall of a patient's vas deference, wherein the apparatus comprises animplantable constriction device for gently constricting a portion of thetissue wall to influence the flow in the lumen, a stimulation device forintermittently and individually stimulating different areas of the wallportion, as the constriction device constricts the wall portion, tocause contraction of the wall portion to further influence the flow inthe lumen, wherein the constriction and stimulation devices form anoperable constriction/stimulation unit, a source of energy, and acontrol device operable from outside the patient's body to control thesource of energy to release energy for use in connection with theoperation of the constriction/stimulation unit. In a simple form of theinvention, the source of energy, such as a battery or accumulator, isimplantable in the patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

In accordance with another aspect of the present invention, there isprovided a male contraception apparatus for obtaining a time-limitedsterility of a male mammalian individual comprising an implantablerestriction device adapted to restrict a vas deference of the malemammalian, and a controller for controlling the restriction device torestrict the vas deference during a controlled period in order toprevent sperms from reaching the urethra, wherein the restriction devicecomprises an implantable constriction device for gently constricting atleast one portion of a tissue wall of the vas deference to influence theflow in the vas deference.

Thus, for some individuals it may suffice to constrict the vas deferenceto achieve the desired result, whereby there is no need for applying thestimulation device. Where applicable, any of the embodiments outlined inthe appended claims could be applied in this apparatus that onlyincludes the constriction device.

The present invention also provides a method for using an apparatus asdescribed above to control a flow of fluid in a lumen formed by a tissuewall of a patient's vas deference, the method comprising providing awireless remote control adapted to control the constriction deviceand/or stimulation device from outside the patient's body, and operatingthe wireless remote control by the patient, when the patient wants toinfluence the flow of fluid in the lumen.

The present invention also provides a method for controlling a flow offluid in a lumen formed by a tissue wall of a patient's vas deference,the method comprising gently constricting at least one portion of thetissue wall to influence the flow in the lumen, and stimulating theconstricted wall portion to cause contraction of the wall portion tofurther influence the flow in the lumen.

Gallstones

Another object of the present invention is to provide a gallstonetrouble treatment apparatus for enhancing the movement of gallstonesfrom the bile ducts to the duodenum, so as to at least substantially oreven completely eliminate the blockage and pain associated withgallstones. One major purpose of the invention is to enable thetransport of gallstones to the duodenum as this relieves the symptoms.Gallstones that reach the duodenum are secreted together with feces.

Herein is also disclosed how flow in the biliary duct can be restrictedby simultaneously using a constriction device and a stimulation device.It may be of importance to be able to completely close the biliary duct.One such occasion is when surgery on the biliary duct is to beperformed.

Furthermore, the apparatus of the invention will be of use to release agallstone, which is lodged in the biliary duct and cannot movedownstream.

In accordance with this object of the present invention, there isprovided a gallstone trouble treatment apparatus for treating a patientsuffering from gallstone trouble, comprising at least one implantablestimulation device configured to stimulate at least one portion of thetissue wall of a biliary duct of the patient, and a control deviceoperable to control the stimulation device to stimulate the tissue wallportion to cause contraction of the tissue wall portion to influence themovement of bile and/or gallstones in the biliary duct.

Specifically, the control device may be operable to control thestimulation device to stimulate the tissue wall portion to causecontractions of the tissue wall portion such that the contractions ofthe tissue wall portion actively move bile and/or gallstones in thebiliary duct.

The apparatus may comprise at least two stimulation devices configuredto stimulate at least two different portions of the tissue wall of thebiliary duct, including the heptic ducts, the common bile duct, thecystic ducts and their sphincters.

In a preferred embodiment, the apparatus further comprises animplantable constriction device configured to gently constrict thetissue wall portion to influence the movement of bile and/or gallstonesin the biliary duct, wherein the control device is operable to controlthe stimulation device to stimulate the tissue wall portion, as theconstriction device constricts the tissue wall portion, to causecontraction of the tissue wall portion to further influence the movementof bile and/or gallstones in the biliary duct.

The present invention provides an advantageous combination ofconstriction and stimulation devices, which results in a two-stageinfluence on the movement of gallstones in the lumen of the biliaryducts. Thus, the constriction device may gently constrict the tissuewall by applying a relatively weak force against the wall portion, andthe stimulation device may stimulate the constricted wall portion toachieve the desired final influence on the movement of bile and/orgallstones in the biliary duct. The phrase “gently constricting aportion of the tissue wall” is to be understood as constricting the wallportion without substantially hampering the blood circulation in thetissue wall.

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the constriction device constricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the biliary duct allows tissue of the wall portion tomaintain substantially normal blood circulation during the operation ofthe apparatus of the invention.

It will be advantageous to be able to calibrate the apparatus.Therefore, in an embodiment of the invention, the constriction device isadjustable to enable adjustment of the constriction of the wall portionas desired, wherein the control device controls the constriction deviceto adjust the constriction of the wall portion. The control device maycontrol the constriction and stimulation devices independently of eachother, and simultaneously. Optionally, the control device may controlthe stimulation device to stimulate, or to not stimulate the wallportion while the control device controls the constriction device tochange the constriction of the wall portion.

Initially, the constriction device may be calibrated by using thecontrol device to control the stimulation device to stimulate the wallportion, while controlling the constriction device to adjust theconstriction of the biliary ducts until the desired restriction of themovement of bile and/or gallstones in the biliary duct is obtained.

The apparatus can be placed so that it can stimulate movement ofgallstones in any of the bilary ducts.

Flow Restriction

As mentioned above, there may be of importance to be able to restrictflow of bile or even completely close the biliary duct. For example whensurgery on the biliary duct is to be performed. The apparatus of thepresent invention is well suited for such a situation. Thus, in aprincipal embodiment of the invention, the constriction device isconfigured to gently constrict the tissue wall portion to restrict themovement of bile and/or gallstones in the biliary duct, and the controldevice is operable to control the stimulation device to stimulate thetissue wall portion, as the constriction device constricts the tissuewall portion, to cause contraction of the tissue wall portion to furtherrestrict the movement of bile and/or gallstones in the biliary duct.Specifically, the constriction device is configured to constrict thewall portion to a constricted state in which the blood circulation inthe constricted wall portion is substantially unrestricted and themovement of bile and/or gallstones in the biliary duct is at leastrestricted, and the control device controls the stimulation device tocause contraction of the wall portion, so that the movement of bileand/or gallstones in the biliary duct is at least further restrictedwhen the wall portion is kept by the constriction device in theconstricted state.

The constriction and stimulation devices may be controlled to constrictand stimulate, respectively, to an extent that depends on the flowrestriction that is desired to be achieved in a specific application ofthe apparatus of the invention. Thus, in accordance with a first flowrestriction option, the control device controls the constriction deviceto constrict the wall portion, such that movement of bile and/orgallstones in the biliary duct is restricted but not stopped, andcontrols the stimulation device to stimulate the constricted wallportion to cause contraction thereof, such that movement of bile and/orgallstones in the biliary duct is further restricted but not stopped.More precisely, the control device may control the stimulation device ina first mode to stimulate the constricted wall portion to furtherrestrict but not stop the movement of bile and/or gallstones in thebiliary duct and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the movement of bile and/orgallstones in the biliary duct; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the movement of bile and/or gallstones in the biliaryduct.

In accordance with a second flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat movement of bile and/or gallstones in the biliary duct isrestricted but not stopped, and controls the stimulation device tostimulate the constricted wall portion to cause contraction thereof,such that movement of bile and/or gallstones in the biliary duct isstopped. More precisely, the control device may control the stimulationdevice in a first mode to stimulate the constricted wall portion tofurther restrict but not stop the movement of bile and/or gallstones inthe biliary duct and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow movement of bile and/orgallstones in the biliary duct; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the movement of bile and/or gallstones in the biliaryduct.

In accordance with a third flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the movement of bile and/or gallstones in the biliary duct issubstantially stopped, and controls the stimulation device to stimulatethe constricted wall portion to cause contraction thereof, such that themovement of bile and/or gallstones in the biliary duct is completelystopped. More precisely, the control device may control the stimulationdevice in a first mode to stimulate the constricted wall portion tocompletely stop the movement of bile and/or gallstones in the billaryduct and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to allow movement of bile and/orgallstones in the biliary duct; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the movement of bile and/or gallstones in the biliaryduct.

Where the stimulation device stimulates the constricted wall portion tocontract, such that the movement of bile and/or gallstones in thebiliary duct is stopped, the control device suitably controls thestimulation device to simultaneously and cyclically stimulate a firstlength of the constricted wall portion and a second length of theconstricted wall portion, which is located downstream of the firstlength, wherein the control device controls the stimulation device toprogressively stimulate the first length in the upstream direction ofthe lumen and to progressively stimulate the second length in thedownstream direction of the lumen.

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the apparatus. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the lumen, such that themovement of bile and/or gallstones in the biliary duct remains stopped.Any sensor for sensing a physical parameter of the patient, such as apressure in the patient's body that relates to the pressure in the lumenmay be provided, wherein the control device controls the stimulationdevice in response to signals from the sensor. Such a sensor may forexample sense the pressure in the patient's abdomen, the pressureagainst the implanted constriction device or the pressure on the tissuewall of the biliary duct.

In accordance with a fourth flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat the movement of bile and/or gallstones in the biliary duct isstopped. More precisely, the control device may control the constrictiondevice in a first mode to constrict the constricted wall portion to stopthe movement of bile and/or gallstones in the biliary duct and in asecond mode to cease the constriction of the wall portion to restoremovement of bile and/or gallstones in the biliary duct. In this case,the control device only controls the stimulation device to stimulate thewall portion when needed. A sensor for sensing a physical parameter ofthe patient's body that relates to the pressure in the lumen may beprovided, wherein the control device controls the stimulation device inresponse to signals from the sensor. Such a physical parameter may be apressure in the patient's abdomen and the sensor may be a pressuresensor.

In some applications of the invention, the implanted constriction devicemay be designed to normally keep the patient's wall portion of thebiliary duct in the constricted state. In this case, the control devicemay be used when needed, conveniently by the patient, to control thestimulation device to stimulate the constricted tissue wall portion,preferably while adjusting the stimulation intensity, to causecontraction of the wall portion, such that the movement of bile and/orgallstones in the biliary duct is at least further restricted orstopped, and to control the stimulation device to cease the stimulation.More precisely, the control device may:

a) control the stimulation device in a first mode to stimulate theconstricted wall portion to further restrict the movement of bile and/orgallstones in the biliary duct, and control the stimulation device in asecond mode to cease the stimulation of the wall portion to increase themovement of bile and/or gallstones in the biliary duct; or

b) control the stimulation device in a first mode to stimulate theconstricted wall portion to stop the movement of bile and/or gallstonesin the biliary duct, and control the stimulation device in a second modeto cease the stimulation of the wall portion to allow movement of bileand/or gallstones in the biliary duct.

Either the first mode or the second mode may be temporary.

The constriction device may include a plurality of separate constrictionelements adapted to constrict any wall portions of a series of wallportions of the biliary duct's tissue wall, respectively. The controldevice may control the constriction device to activate the constrictionelements in random or in accordance with a predetermined sequence. Inthis case, the stimulation device includes stimulation elementspositioned on the constriction elements, wherein the control devicecontrols the stimulation device to activate the stimulation elements tostimulate any wall portions of the series of wall portions constrictedby said constriction elements to contract the biliary duct to close thebiliary duct's lumen.

Alternatively, the control device controls the constriction device toactivate the constriction elements to constrict all of the wall portionsof the series of wall portions, and controls the stimulation device toactivate the stimulation elements to stimulate any constricted wallportions in random or in accordance with a predetermined sequence toclose the biliary duct. The design of the constriction device in theform of a plurality of separate constriction elements makes possible tocounteract growth of hard fibrosis where the constriction device isimplanted.

Movement of Bile and/or Gallstones in the Bilary Duct

Importantly, the apparatus of the invention is specifically suited foractively moving gallstones in the biliary ducts, as described in theembodiments of the invention listed below.

1) The control device controls the constriction device to close thebiliary ducts, at an upstream end of the wall portion, and then controlsthe constriction device to constrict the remaining part of the wallportion to move the gallstones in the biliary duct.

1a) In accordance with a first alternative of the above noted embodiment(1), the control device controls the stimulation device to stimulate thewall portion as the constriction device constricts the remaining part ofthe wall portion.

1b) In accordance with a second alternative, the constriction device isadapted to constrict the wall portion to restrict but not stop the flowin the biliary duct. The control device controls the stimulation deviceto stimulate the wall portion constricted by the constriction device toclose the biliary duct, either at an upstream end or a downstream end ofthe wall portion, and simultaneously controls the constriction device toincrease the constriction of the wall portion to move the gallstones inthe biliary duct.

2) The constriction device is adapted to constrict the wall portion torestrict or very the movement of bile and/or gallstones in the biliaryduct, and the control device controls the stimulation device toprogressively stimulate the constricted wall portion, in the downstreamor upstream direction of the lumen, to cause progressive contraction ofthe wall portion to move the bile and/or gallstones in the biliary duct.

3) The control device controls the constriction device to vary theconstriction of the different areas of the wall portion, such that thewall portion is progressively constricted in the downstream or upstreamdirection of the lumen to move the gallstones in the biliary duct. Theconstriction device may include at least one elongated constrictionelement that extends along the wall portion, wherein the control devicecontrols the elongated constriction element to progressively constrictthe wall portion in the downstream or upstream direction of the biliaryduct.

3a) In accordance with a preferred alternative of the above notedembodiment (3), the control device controls the stimulation device toprogressively stimulate the constricted wall portion to causeprogressive contraction thereof in harmony with the progressiveconstriction of the wall portion performed by the constriction device.Where the constriction device includes at least one elongatedconstriction element the control device controls the elongatedconstriction element to progressively constrict the wall portion in thedownstream or upstream direction of the biliary duct. Suitably, theelongated constriction element comprises contact surfaces dimensioned tocontact a length of the wall portion, when the constriction deviceconstricts the wall portion, and the stimulation device comprises aplurality of stimulation elements distributed along the contactsurfaces, such that the stimulation elements stimulate the differentareas of the wall portion along the length of the wall portion, when thecontrol device controls the stimulation device to stimulate the wallportion.

4) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to at least restrict the movement ofbile and/or gallstones in the biliary duct. The control device controlsthe constriction device to successively constrict the wall portions ofthe series of wall portions to move gallstones in the biliary duct in aperistaltic manner.

4a) In accordance with a first alternative of embodiment (4), theconstriction device includes a plurality of constriction elementsadapted to constrict the wall portions of the tissue wall, respectively.The control device controls the constriction device to activate theconstriction elements one after the other, so that the wall portions ofthe series of wall portions are successively constricted along thebiliary duct, whereby the gallstones are moved.

4b) In accordance with a second alternative of embodiment (4), theconstriction device includes at least one constriction element that ismoveable along the wall of the biliary duct to successively constrictthe wall portions of the series of wall portions, wherein the controldevice controls the constriction device to cyclically move theconstriction element along the wall portions of the series of wallportions. Preferably, the constriction device comprises a plurality ofconstriction elements, each of which is moveable along the wall of thebiliary duct to successively constrict the wall portions of the seriesof wall portions, wherein the control device controls the constrictiondevice to cyclically move the constriction elements one after the otheralong the wall portions of the series of wall portions. Specifically,the constriction device includes a rotor carrying the constrictionelements, and the control device controls the rotor to rotate, such thateach constriction element cyclically constricts the wall portions of theseries of wall portions. Each constriction element suitably comprises aroller for rolling on the wall of the biliary duct to constrict thelatter.

4c) In accordance with a preferred alternative of the above notedembodiment (4), the stimulation device stimulates any of the wallportions of the series of wall portions constricted by the constrictiondevice, to close the lumen. Where the constriction device includes atleast one constriction element, the stimulation device suitably includesat least one stimulation element positioned on the constriction elementfor stimulating the wall portion constricted by the constriction elementto close the biliary duct.

Where the constriction device includes a plurality of constrictionelements, the stimulation device suitably includes stimulation elementspositioned on the constriction elements for stimulating the wallportions constricted by the constriction elements to close the biliaryduct.

5) The constriction device is adapted to constrict any one of a seriesof wall portions of the tissue wall to restrict the movement of bileand/or gallstones in the biliary duct, wherein the constriction deviceincludes a plurality of constriction elements adapted to constrict thewall portions of the tissue wall, respectively, and the stimulationdevice includes stimulation elements positioned on the constrictionelements for stimulating the wall portions constricted by theconstriction elements to close the lumen. The control device controlsthe constriction device to activate the constriction elements toconstrict the wall portions of the series of wall portions withoutcompletely closing the lumen of the biliary duct, and controls thestimulation device to activate the stimulation elements to stimulate thewall portions one after the other, so that the wall portions of theseries of wall portions are successively contracted along the biliaryduct to move the bile and/or gallstones in the lumen of the biliaryduct.

6) The constriction device comprises a first constriction element forconstricting the wall portion at an upstream end thereof, a secondconstriction element for constricting the wall portion at a downstreamend thereof, and a third constriction element for constricting the wallportion between the upstream and downstream ends thereof. The controldevice controls the first, second and third constriction elements toconstrict and release the wall portion independently of one another.More specifically, the control device controls the first or secondconstriction element to constrict the wall portion at the upstream ordownstream end thereof to close the lumen, and controls the thirdconstriction element to constrict the wall portion between the upstreamand downstream ends thereof, whereby the bile and/or gallstonescontained in the wall portion between the upstream and downstream endsthereof is moved downstream or upstream in the lumen. Optionally, thecontrol device controls the stimulation device to stimulate the wallportion between the upstream and downstream ends thereof, when the thirdconstriction element constricts the wall portion.

-   -   6a) In accordance with a first alternative, the control device        controls the first constriction element to constrict the wall        portion at the upstream end thereof to restrict the movement of        bile and/or gallstones in the biliary duct and controls the        stimulation device to stimulate the constricted wall portion at        the upstream end to close the lumen. With the lumen closed at        the upstream end of the constricted wall portion, the control        device controls the third constriction element to constrict the        wall portion between the upstream and downstream ends thereof,        and optionally controls the stimulation device to simultaneously        stimulate the wall portion as the latter is constricted by the        third constriction element. As a result, the gallstones        contained in the wall portion between the upstream and        downstream ends thereof is moved downstream in the lumen.    -   6b) In accordance with a second alternative, the control device        controls the second constriction element to constrict the wall        portion at the downstream end thereof to restrict the movement        of bile and/or gallstones in the biliary duct and controls the        stimulation device to stimulate the constricted wall portion at        the downstream end to close the lumen. With the lumen closed at        the downstream end of the constricted wall portion, the control        device controls the third constriction element to constrict the        wall portion between the upstream and downstream ends thereof,        and optionally controls the stimulation device to simultaneously        stimulate the wall portion as the latter is constricted by the        third constriction element. As a result, the gallstones        contained in the wall portion between the upstream and        downstream ends thereof is moved upstream in the lumen. This can        be used to release gallstones that are stuck in the biliary        ducts. These gallstones are subsequently moved downstream,        towards the duodenum.

In any of the above noted embodiments (1) to (6b), the stimulationdevice may stimulate the wall portion with electric pulses.

The biliary duct may be surgically prepared to extend in zigzag withadjacent walls stitched together by two parallel rows of stitches andwith the adjacent walls cut through between the two rows of stitches. Asa result, the lumen of this long wall portion of the biliary duct can besignificantly expanded. In this case, the constriction device of theapparatus of the invention is able to move a considerably larger volumeof fluid each time it constricts the long wall portion of the biliaryduct.

The various solutions described above under the headline: “Flowrestriction” to stop the flow in the lumen of the biliary duct may alsobe used in any of the above noted embodiments (1a), (1b), (4a), (5),(6), (6a) and (6b).

Importantly, in any of the embodiments above, movement of bile and/orgallstones may be carried out with electric stimulation only. Thus, insuch an embodiment, there is no need for a constriction device.

Stimulation

When stimulating neural or muscular tissue there is a risk of injuringor deteriorating the tissue over time, if the stimulation is notproperly performed. The apparatus of the present invention is designedto reduce or even eliminate that risk. Thus, in accordance with thepresent invention, the control device controls the stimulation device tointermittently stimulate different areas of the wall portion of thebiliary duct, such that at least two of the areas are stimulated atdifferent points of time that is, the stimulation is shifted from onearea to another area over time. In addition, the control device controlsthe stimulation device, such that an area of the different areas thatcurrently is not stimulated has time to restore substantially normalblood circulation before the stimulation device stimulates the areaagain. Furthermore, the control device controls the stimulation deviceto stimulate each area during successive time periods, wherein each timeperiod is short enough to maintain satisfactory blood circulation in thearea until the lapse of the time period. This gives the advantage thatthe apparatus of the present invention enables continuous stimulation ofthe wall portion of the biliary duct to achieve the desired flowcontrol, while essentially maintaining over time the natural physicalproperties of the biliary duct without risking injuring the biliaryduct.

Also, by physically changing the places of stimulation on the biliaryduct over time as described above it is possible to create anadvantageous changing stimulation pattern on the biliary duct, in orderto achieve a desired flow control.

The control device may control the stimulation device to stimulate oneor more of the areas of the wall portion at a time, for example bysequentially stimulating the different areas. Furthermore, the controldevice may control the stimulation device to cyclically propagate thestimulation of the areas along the wall portion, preferably inaccordance with a determined stimulation pattern. To achieve the desiredreaction of the tissue wall during the stimulation thereof, the controldevice may control the stimulation device to, preferably cyclically,vary the intensity of the stimulation of the wall portion.

In a preferred embodiment of the invention, the control device controlsthe stimulation device to intermittently stimulate the areas of the wallportion with pulses that preferably form pulse trains. At least a firstarea and a second area of the areas of the wall portion may berepeatedly stimulated with a first pulse train and a second pulse train,respectively, such that the first and second pulse trains over time areshifted relative to each other. For example, the first area may bestimulated with the first pulse train, while the second area is notstimulated with said second pulse train, and vice versa. Alternatively,the first and second pulse trains may be shifted relative to each other,such that the first and second pulse trains at least partially overlapeach other.

The pulse trains can be configured in many different ways. Thus, thecontrol device may control the stimulation device to vary the amplitudesof the pulses of the pulse trains, the duty cycle of the individualpulses of each pulse train, the width of each pulse of the pulse trains,the length of each pulse train, the repetition frequency of the pulsesof the pulse trains, the repetition frequency of the pulse trains, thenumber of pulses of each pulse train, and/or the off time periodsbetween the pulse trains. Several pulse trains of differentconfigurations may be employed to achieve the desired effect.

In case the control device controls the stimulation device to vary theoff time periods between pulse trains that stimulate the respective areaof the wall portion, it is also possible to control each off time periodbetween pulse trains to last long enough to restore substantially normalblood circulation in the area when the latter is not stimulated duringthe off time periods.

Electric Stimulation

In accordance with a preferred embodiment of the invention, thestimulation device is an electrically powered stimulation device thatelectrically stimulates the tissue wall portion of the patient's biliaryduct, preferably with electric pulses. This embodiment is particularlysuited for applications in which the wall portion includes muscle fibersthat react to electrical stimula. In this embodiment, the control devicecontrols the stimulation device to stimulate the wall portion withelectric pulses preferably in the form of electric pulse trains, whenthe wall portion is in the constricted state, to cause contraction ofthe wall portion. Of course, the configuration of the electric pulsetrains may be similar to the above described pulse trains and thecontrol device may control the stimulation device to electricallystimulate the different areas of the wall of the biliary duct in thesame manner as described above.

The electric stimulation device suitably comprises at least one,preferably a plurality of electrical elements, such as electrodes, forengaging and stimulating the well portion with electric pulses.Optionally, the electrical elements may be placed in a fixed orientationrelative to one another. The control device controls the electricstimulation device to electrically energize the electrical elements, oneat a time, or groups of electrical elements at a time. Preferably, thecontrol device controls the electric stimulation device to cyclicallyenergize each element with electric pulses. Optionally, the controldevice may control the stimulation device to energize the electricalelements, such that the electrical elements are energized one at a timein sequence, or such that a number or groups of the electrical elementsare energized at the same time. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with apredetermined pattern.

The electrical elements may form any pattern of electrical elements.Preferably, the electrical elements form an elongate pattern ofelectrical elements, wherein the electrical elements are applicable onthe patient's wall of the biliary duct, such that the elongate patternof electrical elements extends lengthwise along the wall of the biliaryduct, and the elements abut the respective areas of the wall portion.The elongate pattern of electrical elements may include one or more rowsof electrical elements extending lengthwise along the wall of thebiliary duct. Each row of electrical elements may form a straight,helical or zig-zag path of electrical elements, or any form of path. Thecontrol device may control the stimulation device to successivelyenergize the electrical elements longitudinally along the elongatepattern of electrical elements in a direction opposite to, or in thesame direction as that of, the flow in the patient's biliary duct.

Optionally, the control device may control the stimulation device tosuccessively energize the electrical elements from a positionsubstantially at the center of the constricted wall portion towards bothends of the elongate pattern of electrical elements. Where the biliaryduct is to be kept closed for a relatively long time, the control devicemay control the stimulation device to energize the electrical elements,such that energized electrical elements form two waves of energizedelectrical elements that simultaneously advance from the center of theconstricted wall portion in two opposite directions towards both ends ofthe elongate pattern of electrical elements. Such waves of energizedelectrical elements can be repeated over and over again without harmingthe biliary duct and without moving matter in any direction in the lumenof the biliary duct.

The control device suitably controls the stimulation device to energizethe electrical elements, such that the electrical elements currentlyenergized form at least one group of adjacent energized electricalelements. In accordance with a first alternative, the elements in thegroup of energized electrical elements form one path of energizedelectrical elements. The path of energized electrical elements mayextend at least in part around the patient's biliary duct. In a secondalternative, the elements of the group of energized electrical elementsmay form two paths of energized electrical elements extending on mutualsides of the patient's biliary duct, preferably substantially transverseto the flow direction in the lumen of the biliary duct. In a thirdalternative, the elements of the group of energized electrical elementsmay form more than two paths of energized electrical elements extendingon different sides of the biliary duct, preferably substantiallytransverse to the flow direction in the lumen of the biliary duct.

In accordance with a preferred embodiment of the invention, theelectrical elements form a plurality of groups of elements, wherein thegroups form a series of groups extending along the biliary duct in theflow direction in the patient's lumen. The electrical elements of eachgroup of electrical elements may form a path of elements extending atleast in part around the biliary duct. In a first alternative, theelectrical elements of each group of electrical elements may form morethan two paths of elements extending on different sides of the bilaryduct, preferably substantially transverse to the flow direction in thepatient's lumen. The control device may control the stimulation deviceto energize the groups of electrical elements in the series of groups inrandom, or in accordance with a predetermined pattern. Alternatively,the control device may control the stimulation device to successivelyenergize the groups of electrical elements in the series of groups in adirection opposite to, or in the same direction as that of, the flow inthe patient's bilary duct, or in both said directions starting from aposition substantially at the center of the constricted wall portion.For example, groups of energized electrical elements may form advancingwaves of energized electrical elements, as described above; that is, thecontrol device may control the stimulation device to energize the groupsof electrical elements, such that energized electrical elements form twowaves of energized electrical elements that simultaneously advance fromthe center of the constricted wall portion in two opposite directionstowards both ends of the elongate pattern of electrical elements.

A structure may be provided for holding the electrical elements in afixed orientation. Although the structure may be separate from theconstriction device, it is preferable that the structure is integratedin the constriction device, which is a practical design and facilitatesimplantation of the constriction and stimulation devices. Where theelectrical elements form an elongate pattern of electrical elements, thestructure may be applicable on the patient's biliary duct such that theelongate pattern of electrical elements extends along the biliary ductin the same direction as that of the flow in the bilary duct and theelements abut the respective areas of the wall portion of the biliaryduct.

Thermal Stimulation

In another embodiment of the invention, the stimulation device thermallystimulates the wall portion of the biliary duct. Thus, the controldevice may control the stimulation device to cool the wall portion, whenthe wall portion is constricted, to cause contraction of the wallportion. For example, the constriction device may constrict the wallportion to at least restrict the movement of bile and/or gallstones inthe biliary duct, and the control device may control the stimulationdevice to cool the constricted wall portion to cause contractionthereof, such that the movement of bile and/or gallstones in the biliaryduct is at least further restricted, or further restricted but notstopped, or stopped. Alternatively, the control device may control thestimulation device to heat the wall portion, when the wall portion isconstricted and contracted, to cause expansion of the wall portion.Where applicable, thermal stimulation may be practised in any of theembodiments of the present Invention, and the thermal stimulation may becontrolled in response to various sensors, for example strain, motion orpressure sensors.

Sensor Controlled Constriction and/or Stimulation Device

As mentioned above, the apparatus may comprise at least one implantablesensor, wherein the control device controls the constriction deviceand/or the stimulation device in response to signals from the sensor.Generally, the sensor directly or indirectly senses at least onephysical parameter of the patient, or at least one functional parameterof the apparatus, or at least one functional parameter of a medicalimplant in the patient.

Many different kinds of sensor for sensing physical parameters may beused. For example motion sensors for sensing biliary duct motion, i.e.natural contractions, such contractions, pressure sensors for sensingpressure in the biliary duct, strain sensors for sensing strain of thebiliary duct, flow sensors for sensing fluid movement of bile and/orgallstones in the biliary duct of the biliary duct,spectro-photometrical sensors, Ph-sensors for sensing acidity oralkalinity of the fluid in the lumen of the biliary duct, oxygen-sensorssensors for sensing the oxygen content of the fluid in the lumen of thebiliary duct, or sensors for sensing the distribution of the stimulationon the stimulated biliary duct. Any conceivable sensors for sensing anyother kind of useful physical parameter may be used.

Many different kinds of sensors that sense functional parameters of theapparatus may also be used for the control of the constriction deviceand/or the stimulation device. For example sensors for sensing electricparameters of implanted electric components of the apparatus, or sensorsfor sensing the performance of implanted motors of the apparatus.

The sensor may comprise a pressure sensor for sensing as the physicalparameter a pressure in the patient's body that relates to the pressurein the lumen of the biliary duct, wherein the control device controlsthe constriction device and/or stimulation device to change theconstriction of the patient's wall portion in response to the pressuresensor sensing a predetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a positionsensor may be provided for sensing as the physical parameter theorientation of the patient with respect to the horizontal. The positionsensor may be a biocompatible version of what is shown in U.S. Pat. Nos.4,942,668 and 5,900,909. For example, the control device may control theconstriction device and/or stimulation device to change the constrictionof the patient's wall portion in response to the position sensor sensingthat the patient has assumed a substantially horizontal orientation,i.e. that the patient is lying down.

The above described sensors may be used in any of the embodiments of theinvention, where applicable.

The control device may control the constriction device and/orstimulation device to change the constriction of the patient's wallportion in response to the time of day. For that purpose the controldevice may include a clock mechanism for controlling the constrictiondevice and/or stimulation device to change the constriction of thepatient's wall portion to increase or decrease the influence on themovement of bile and/or gallstones in the biliary duct during differenttime periods of the day. In case a sensor of any of the above-describedtypes for sensing a physical or functional parameter is provided, eitherthe clock mechanism is used for controlling the constriction deviceand/or stimulation device provided that the parameter sensed by thesensor does not override the clock mechanism, or the sensor is used forcontrolling the constriction device and/or stimulation device providedthat the dock mechanism does not override the sensor. Suitably, thecontrol device produces an indication, such as a sound signal ordisplayed information, in response to signals from the sensor.

The control device may comprise an implantable internal control unitthat directly controls the constriction device and/or stimulation devicein response to signals from the sensor. The control device may furthercomprise a wireless remote control adapted to set control parameters ofthe internal control unit from outside the patient without mechanicallypenetrating the patient. At least one of the control parameters, whichare settable by the wireless remote control, is the physical orfunctional parameter. Suitably, the internal control unit includes theabove mentioned dock mechanism, wherein the wireless remote control alsois adapted to set the dock mechanism.

Alternatively, the control device may comprise an external control unitoutside the patient's body for controlling the constriction deviceand/or stimulation device in response to signals from the sensor.

Adjustable Constriction Device

In several alternative embodiments of the invention, the constrictiondevice is adjustable. In these embodiments, there is an operation devicefor operating the adjustable constriction device to change theconstriction of the patient's tissue wall portion, and the constrictionand stimulation devices form a constriction/stimulation unit.Preferably, the constriction and stimulation devices of theconstriction/stimulation unit are integrated in a single piece suitablefor implantation. The constriction device of the unit comprises contactsurfaces dimensioned to contact a length of a tissue wall portion of apatient's biliary duct, and the stimulation device of the unit comprisesa plurality of stimulation elements provided on and distributed alongthe contact surfaces. When the control device controls the stimulationdevice to stimulate the wall portion, the stimulation elements stimulatedifferent areas of the wall portion along the length of the wallportion. The stimulation elements preferably comprise electric elements,as described above, for stimulating the wall portion with electricpulses. However, in most applications of the present invention, otherkinds of stimulations, such as thermal stimulation, could be suitable toemploy.

The operation device operates the adjustable constriction device of theconstriction/stimulation unit in a manner that depends on the design ofthe constriction device, as will be explained by the following examplesof embodiments. 1) The constriction device comprises at least twoelongated clamping elements having the contact surfaces and extendingalong the wall portion on different sides of the biliary duct, and theoperation device operates the clamping elements to clamp the wallportion between the clamping elements to constrict the wall portion ofthe biliary duct.

2) The constriction device comprises one elongate clamping elementhaving the contact surfaces and extending along the wall portion on oneside of the biliary duct, and the operation device operates the clampingelement to clamp the wall portion between the clamping element and thebone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engagement elementshaving the contact surfaces and positioned on different sides of thebiliary duct, and the operation device rotates the engagement elements,such that the engagement elements engage and constrict the wall portionof the biliary duct.

4) The constriction device comprises at least two articulated clampingelements having the contact surfaces and positioned on different sidesof the biliary duct, and the operation device moves the clampingelements towards each other to clamp the wall portion of the biliaryduct between the clamping elements, to constrict the wall portion.

5) The constriction device comprises at least two separate clampingelements having the contact surfaces, at least one of the clampingelements being pivoted, such that it may turn in a plane in which theloop of the constriction member extends, and the operation device turnsthe pivoted clamping element to change the size of the constrictionopening.

6) The constriction device comprises at least one elongated constrictionmember having the contact surfaces, and forming means for forming theconstriction member into at least a substantially closed loop around thebiliary duct, wherein the loop defines a constriction opening. Theoperation device operates the constriction member in the loop to changethe size of the constriction opening.

6a) The elongated constriction member comprises a belt having thecontact surfaces, and the operation device operates the belt to changethe longitudinal extension of the belt in the loop to change the size ofthe constriction opening. The forming means may form the constrictionmember or belt into a loop having at least one predetermined size.

6b) The elongated constriction member is operable to change the size ofthe constriction opening, such that the outer circumferentialconfinement surface of the constriction device is changed, or,alternatively, is unchanged.

6c) The elongated constriction member is elastic and varies in thicknessas seen in a cross-section there through, and is operable to turn aroundthe longitudinal extension of the constriction member.

6d) The elongated constriction member comprises two substantially orpartly semi-circular frame elements having the contact surfaces andhinged together, such that the semi-circular elements are swingablerelative to each other from a fully open state in which theysubstantially or partly form a circle to a fully folded state in whichthey substantially form a semi-circle.

7) The constriction device is adapted to bend the wall portion of thebiliary duct to constrict the latter.

In the above noted embodiments (1) to (7), it is important that theconstriction device is designed to constrict said length of the tissuewall portion of the biliary duct. For this purpose, the constrictiondevice may include two or more of the described constrictionelements/members to be applied in a row along said length of the wallportion, wherein said row extends in the direction of movement of bileand/or gallstones in the biliary duct of the biliary duct. Preferably,such constriction elements/members are non-inflatable and mechanicallyoperable or adjustable.

In the above noted embodiments (1) to (7), the operation device mayeither mechanically or hydraulically adjust the constriction device ofthe constriction/stimulation unit. Also, the operation device maycomprise an electrically powered operation device for operating theconstriction device. For many applications of the present invention, theoperation device suitably operates the constriction device, such thatthe through-flow area of the lumen assumes a size in the constrictedstate that enables the stimulation device to contract the wall portionsuch that the movement of bile and/or gallstones in the biliary duct isstopped.

Mechanical Operation

Where the operation device mechanically operates the constriction deviceof the constriction/stimulation unit, it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Hydraulic Operation

Where the operation device hydraulically operates the constrictiondevice of the constriction/stimulation unit, it includes hydraulic meansfor adjusting the constriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the tissuewall portion of the patient's biliary duct, so that the patient's wallportion is constricted upon expansion of the cavity and released uponcontraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The operation device comprises a pump for pumping fluid between thereservoir and the cavity.

2a) The pump comprises a first activation member for activating the pumpto pump fluid from the reservoir to the cavity and a second activationmember for activating the pump to pump fluid from the cavity to thereservoir.

2a1) The first and second activation members are operable by manualmanipulation thereof.

-   -   2a2) At least one of the activation members operates when        subjected to an external predetermined pressure.

2a3) At least one of the first and second activating members is operableby magnetic means, hydraulic means, or electric control means.

2b) The apparatus comprises a fluid conduit between the pump and thecavity, wherein the reservoir forms part of the conduit. The conduit andpump are devoid of any non-return valve. The reservoir forms a fluidchamber with a variable volume, and the pump distributes fluid from thechamber to the cavity by a reduction in the volume of the chamber andwithdraws fluid from the cavity by an expansion of the volume of thechamber. The apparatus further comprises a motor for driving the pump,wherein the pump comprises a movable wall of the reservoir for changingthe volume of the chamber.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, the cavitycan be exchanged by a cylinder/piston mechanism for adjusting theconstriction device. In this case, the operation device distributeshydraulic fluid between the reservoir and the cylinder/piston mechanismto adjust the constriction device.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoir hydraulicallyconnected to the servo reservoir to form a closed conduit system for theservo fluid. The expandable servo reservoir has first and second wallportions, which are displaceable relative to each other in response to achange in the volume of the expandable servo reservoir.

In accordance with a first alternative, the first and second wallportions of the servo reservoir are operatively connected to thehydraulic means. The reverse servo distributes fluid between the fluidsupply reservoir and the expandable servo reservoir to change the volumeof the servo reservoir, whereby the hydraulic means is operated toadjust the constriction device.

In accordance with a second alternative, there is provided animplantable main reservoir containing a predetermined amount ofhydraulic fluid, wherein the reverse servo is operable to distributehydraulic fluid between the main reservoir and the hydraulic means toadjust the constriction device. More specifically, the main reservoir isprovided with first and second wall portions operatively connected tothe first and second wall portions of the expandable servo reservoir,such that the volume of the main reservoir is changed when the volume ofthe expandable servo reservoir is changed. Thus, when the reverse servodistributes servo fluid between the fluid supply reservoir and theexpandable servo reservoir to change the volume of the main reservoir,hydraulic fluid is distributed from the main reservoir to the hydraulicmeans, or from the hydraulic means to the main reservoir.Advantageously, the servo and main reservoirs are dimensioned, such thatwhen the volume of the servo reservoir is changed by a relatively smallamount of servo fluid, the volume of the main reservoir is changed by arelatively large amount of hydraulic fluid.

In both of the above-described alternatives, the fluid supply reservoirmay have first and second wall portions, which are displaceable relativeto each other to change the volume of the fluid supply reservoir todistribute servo fluid between the fluid supply reservoir and theexpandable servo reservoir. The first and second wall portions of thefluid supply reservoir may be displaceable relative to each other bymanual manipulation, a magnetic device, a hydraulic device, or anelectric control device to change the volume of the fluid supplyreservoir to distribute servo fluid between the fluid supply reservoirand the expandable servo reservoir.

In all of the above noted embodiments 1 to 2b where the hydraulic meanscomprises an expandable cavity in the constriction device, or inembodiments where the hydraulic means comprises a hydraulically operablemechanical construction, the operation device may include the reverseservo described above. In a further embodiment of the invention, thehydraulic means include first and second hydraulically interconnectedexpandable/contractible reservoirs. The first reservoir is operativelyconnected to the constriction device, such that the constriction devicechanges the constriction of the patient's wall portion upon expansion orcontraction of the first reservoir. By changing the volume of the secondreservoir hydraulic fluid is distributed between the two reservoirs, sothat the first reservoir is either expanded or contracted. Thisembodiment requires no non-return valve in the fluid communicationconduits between the two reservoirs, which is beneficial to long-termoperation of the hydraulic means.

Alternatively, the hydraulic means may include first and secondhydraulically interconnected piston/cylinder mechanisms instead of thefirst and second reservoirs described above. The first piston/cylindermechanism is operatively connected to the constriction device, such thatthe constriction device changes the constriction of the patient's wallportion upon operation of the first piston/cylinder mechanism. Byoperating the second piston/cylinder mechanism hydraulic fluid isdistributed between the two piston/cylinder mechanisms, so that thefirst piston/cylinder mechanism adjusts the constriction device.

Where the constriction device does not include anexpandable/contractible cavity, the constriction device may comprise atleast two elongated clamping elements having the above-mentioned contactsurfaces and extending along the wall portion on different sides of thebiliary duct. The hydraulic means, which may include the reverse servodescribed above, hydraulically moves the elongated clamping elementstowards the wall portion to constrict the wall portion. For example, theconstriction device may have hydraulic chambers in which the clampingelements slide back and forth, and the hydraulic means may also includea pump and an implantable reservoir containing hydraulic fluid. The pumpdistributes hydraulic fluid from the reservoir to the chambers to movethe clamping elements against the wall portion, and distributeshydraulic fluid from the chambers to the reservoir to move the clampingelements away from the wall portion.

Design of Control Device

The control device suitably controls the constriction/stimulation unitfrom outside the patient's body. Preferably, the control device isoperable by the patient. For example, the control device may comprise amanually operable switch for switching on and off theconstriction/stimulation unit, wherein the switch is adapted forsubcutaneous implantation in the patient to be manually or magneticallyoperated from outside the patient's body. Alternatively, the controldevice may comprise a hand-held wireless remote control, which isconveniently operable by the patient to switch on and off theconstriction/stimulation unit. The wireless remote control may also bedesigned for application on the patient's body like a wristwatch. Such awristwatch type of remote control may emit a control signal that followsthe patient's body to implanted signal responsive means of theapparatus.

Where the control device wirelessly controls theconstriction/stimulation unit from outside the patient's body, thewireless control function is preferably performed in a non-magneticmanner, i.e., the control device controls the constriction device of theconstriction/stimulation unit in a non-magnetic manner. The patient mayuse the remote control to control the constriction/stimulation unit toadjust the stimulation intensity and/or adjust the constriction of thewall portion. The wireless remote control may comprise at least oneexternal signal transmitter or transceiver and at least one internalsignal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wirelesscontrol signal for controlling the constriction/stimulation unit. Thecontrol signal may comprise a frequency, amplitude, phase modulatedsignal or a combination thereof, and may be an analogue or a digitalsignal, or a combination of an analogue and digital signal. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analogue control signal. Also the carrier signal maycomprise digital, analogue or a combination of digital and analoguesignals.

Any of the above control signals may comprise wave signals, for examplea sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.Alternatively, the control signal may comprise an electric or magneticfield, or a combined electric and magnetic field.

As mentioned above, the control signal may follow the patient's body toimplanted signal responsive means of the apparatus.

The control device may include a programmable internal control unit,such as a microprocessor, implantable in the patient for controlling theconstriction/stimulation unit. The control device may further include anexternal control unit intended to be outside the patient's body, whereinthe internal control unit is programmable by the external control unit.For example, the internal control unit may be programmable forcontrolling the constriction/stimulation unit over time, suitably inaccordance with an activity schedule program. The apparatus of theinvention may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator feeds data related tothe constriction/stimulation unit back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Source of Energy

The present invention also presents a solution for supplying energy foruse in connection with the operation of the constriction/stimulationunit. Thus, in a broad sense, the present invention provides anapparatus for controlling a flow of bile and/or gallstones in a lumenformed by a tissue wall of a patient's biliary duct, wherein theapparatus comprises an implantable constriction device for gentlyconstricting a portion of the tissue wall to influence the movement ofbile and/or gallstones in the biliary duct, a stimulation device forintermittently and individually stimulating different areas of the wallportion, as the constriction device constricts the wall portion, tocause contraction of the wall portion to further influence the movementof bile and/or gallstones in the biliary duct, wherein the constrictionand stimulation devices form an operable constriction/stimulation unit,a source of energy, and a control device operable from outside thepatient's body to control the source of energy to release energy for usein connection with the operation of the constriction/stimulation unit.In a simple form of the invention, the source of energy, such as abattery or accumulator, is implantable in the patient's body.

Transmission of Wireless Energy

In a more sophisticated form of the invention, which is preferable, thesource of energy is external to the patient's body and the controldevice controls the external source of energy to release wirelessenergy. In this sophisticated form of the invention, the apparatuscomprises an energy-transmission device that transmits the releasedwireless energy from outside the patient's body to inside the patient'sbody. Among many things the wireless energy may comprise electromagneticenergy, an electric field, an electromagnetic field or a magnetic field,or a combination thereof, or electromagnetic waves. Theenergy-transmission device may transmit wireless energy for direct usein connection with the operation of the constriction/stimulation unit,as the wireless energy is being transmitted. For example, where anelectric motor or pump operates the constriction device, wireless energyin the form of a magnetic or an electromagnetic field may be used fordirect power of the motor or pump.

Thus, the motor or pump is running directly during transmission of thewireless energy. This may be achieved in two different ways: a) using atransforming device implanted in the patient to transform the wirelessenergy into energy of a different form, preferably electric energy, andpowering the motor or pump with the transformed energy, or b) using thewirelessly transmitted energy to directly power the motor or pump.Preferably wireless energy in the form of an electromagnetic or magneticfield is used to directly influence specific components of the motor orpump to create kinetic energy for driving the motor or pump. Suchcomponents may include coils integrated in the motor or pump, ormaterials influenced by magnetic fields, or permanent magnets, whereinthe magnetic or electromagnetic field influences the coils to generate acurrent for driving the motor or pump, or influences the material orpermanent magnets to create kinetic energy for driving the motor orpump.

Preferably, the energy-transmission device transmits energy by at leastone wireless signal, suitably a wave signal. The wave signal maycomprise an electromagnetic wave signal Including one of an infraredlight signal, a visible light signal, an ultra violet light signal, alaser signal, a microwave signal, a radio wave signal, an x-rayradiation signal, and a gamma radiation signal. Alternatively, the wavesignal may comprise a sound or ultrasound wave signal. The wirelesssignal may be a digital or analogue signal, or a combination of adigital and analogue signal.

Transforming Wireless Energy

In accordance with a particular embodiment of the invention, animplantable energy-transforming device is provided for transformingwireless energy of a first form transmitted by the energy-transmissiondevice into energy of a second form, which typically is different fromthe energy of the first form. The constriction/stimulation unit isoperable in response to the energy of the second form. For example, thewireless energy of the first form may comprise sound waves, whereas theenergy of the second form may comprise electric energy. In this case,the energy-transforming device may include a piezo-electric element fortransforming the sound waves into electric energy. Optionally, one ofthe energy of the first form and the energy of the second form maycomprise magnetic energy, kinetic energy, sound energy, chemical energy,radiant energy, electromagnetic energy, photo energy, nuclear energy orthermal energy. Preferably, one of the energy of the first form and theenergy of the second form is non-magnetic, non-kinetic, non-chemical,non-sonic, non-nuclear or non-thermal.

The energy-transforming device may function differently from or similarto the energy-transmission device. In a special embodiment, theenergy-transforming device comprises at least one element, such as atleast one semiconductor, having a positive region and a negative region,when exposed to the energy of the first form transmitted by theenergy-transmission device, wherein the element is capable of creatingan energy field between the positive and negative regions, and theenergy field produces the energy of the second form. More specifically,the element may comprise an electrical junction element, which iscapable of inducing an electric field between the positive and negativeregions when exposed to the energy of the first form transmitted by theenergy-transmission device, whereby the energy of the second formcomprises electric energy.

The energy-transforming device may transform the energy of the firstform directly or indirectly into the energy of the second form. Animplantable motor or pump for operating the constriction device of theconstriction/stimulation unit may be provided, wherein the motor or pumpis powered by the energy of the second form. The constriction device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function. For example, the controldevice may shift polarity of the energy of the second form to reversethe motor.

The energy-transforming device may directly power the motor or pump withthe transformed energy, as the energy of the second form is beingtransformed from the energy of the first form. Preferably, theenergy-transforming device directly operates theconstriction/stimulation unit with the energy of the second form in anon-magnetic, non-thermal or non-mechanical manner.

Normally, the constriction/stimulation unit comprises electriccomponents that are energized with electrical energy. Other implantableelectric components of the apparatus may be at least one voltage levelguard or at least one constant current guard. Therefore, theenergy-transforming device may transform the energy of the first forminto a direct current or pulsating direct current, or a combination of adirect current and pulsating direct current. Alternatively, theenergy-transforming device may transform the energy of the first forminto an alternating current or a combination of a direct and alternatingcurrent.

The apparatus of the invention may comprise an internal source of energyimplantable in the patient for supplying energy for the operation of theconstriction/stimulation unit. The apparatus may further comprise animplantable switch operable to switch from an “off” mode, in which theinternal source of energy is not in use, to an “on” mode, in which theinternal source of energy supplies energy for the operation of theconstriction/stimulation unit, and/or for energizing implantedelectronic components of the apparatus. The switch may be operable bythe energy of the first form transmitted by the energy-transmissiondevice or by the energy of the second form supplied by theenergy-transforming device. The described switch arrangement reducespower consumption of the apparatus between operations.

The internal source of energy may store the energy of the second formsupplied by the energy-transforming device. In this case, the internalsource of energy suitably comprises an accumulator, such as at least onecapacitor or at least one rechargeable battery, or a combination of atleast one capacitor and at least one rechargeable battery. Where theinternal source of energy is a rechargeable battery it may be chargedonly at times convenient for the patient, for example when the patientis sleeping. Alternatively, the internal source of energy may supplyenergy for the operation of the constriction/stimulation unit but not beused for storing the energy of the second form. In this alternative, theinternal source of energy may be a battery and the switch describedabove may or may not be provided.

Suitably, the apparatus of the invention comprises an implantablestabilizer for stabilizing the energy of the second form. Where theenergy of the second form is electric energy the stabilizer suitablycomprises at least one capacitor.

The energy-transforming device may be designed for implantationsubcutaneously in the abdomen, thorax or cephalic region of the patient.Alternatively, it may be designed for implantation in an orifice of thepatient's body and under the mucosa or intramuscularly outside themucosa of the orifice.

Although the constriction/stimulation unit in the embodiments describedabove is designed as a single piece, which is most practical forimplantation, it should be noted that as an alternative the constrictiondevice and stimulation device could be designed as separate pieces. Anyone of the constriction and stimulation units described above mayalternatively be replaced by two or more separateconstriction/stimulation elements, which are controlled independently ofone another.

The above-described apparatus of the invention is suited for treatingdysfunctions of a biliary duct, for example gallstones, of a human beingor animal.

The present invention also provides a method for using an apparatus asdescribed above to control a flow of bile and/or gallstones in a lumenformed by a tissue wall of a patient's biliary duct, the methodcomprising:

providing a wireless remote control adapted to control the constrictiondevice and/or stimulation device from outside the patient's body, and

operating the wireless remote control by the patient, when the patientwants to influence the flow of bile and/or gallstones in the lumen.

The present invention also provides a method for controlling a flow ofbile and/or gallstones in a lumen formed by a tissue wall of a patient'sbiliary duct, the method comprising a) gently constricting at least oneportion of the tissue wall to influence the movement of bile and/orgallstones in the biliary duct, and b) stimulating the constricted wallportion to cause contraction of the wall portion to further influencethe movement of bile and/or gallstones in the biliary duct.

Pregnancy Promotion

Another object of the present invention ist to provide a pregnancycontrol apparatus for promoting pregnancy.

In accordance with this object of the present invention, there isprovided a pregnancy control apparatus for treating a female patientcomprising a restriction device configured to postoperatively beadjusted to restrict and release an oviduct of the patient.

The inventive device allows the egg from the ovary to be retained in theoviduct for a couple of days to be able to achieve the right timing foregg release and thereby increasing the likelihood to get pregnant withup to 10 times. A respective restriction pregnancy device is placed onthe two oviducts to restrict and release the oviduct, thereby effectingthe above mentioned retaining of the egg.

In accordance with a first aspect of the present invention, there isprovided a device for treating a female patient to promote pregnancycomprising a device adapted to postoperatively restrict and release anoviduct of the patient. To reduce any possible risk of the egg being tothe wall of the oviduct the restriction device may be combined with amovement device. Such a device may comprise a vibrating device or astimulating device. The stimulation device may create a peristaltic likewave in the oviduct. For example, a vibrating device may be provided,which causes vibrations in a hydraulic fluid or mechanically causesvibrations in the wall of the oviduct. Another embodiment is anelectrical stimulation device causing contractions or stimulation wavesin the upstream direction of the oviduct. The device may also bereplaced by a device not permitting the flow of the egg down to theuterus but without any full restriction. This may be created by using adevice causing a peristaltic like wave in the oviduct in the directionof the ovary, thus without fully closing the oviduct instead preventingfurther transport of the egg down to the uterus by the wave, but stillallowing the sperm to reach the egg. Any possible device withoutrestriction at all or in any combinations of partly restriction orvibration or stimulation may be used. This will then allow the egg to beaccumulated in the oviduct and allowing conception to take place over alonger period of time.

In accordance with a second aspect of the invention, there is provided amethod of promoting pregnancy of a female patient, comprising the stepsof restricting an oviduct of the patient to provide a restriction toaccumulate at least one egg released from the ovary in the oviduct for apredetermined period of time, and releasing the restriction to admit theat least on egg in the oviduct to allow a transport of the at least oneegg to the uterus.

The restriction device is adapted to provide a restriction of theoviduct to accumulate at least one egg released from the ovary in theoviduct and to provide a release of the oviduct after accumulating theegg normally up to three days when pregnancy is wanted to achieve righttiming for pregnancy.

The restriction device may be adapted to be adjusted from outside thepatients body to restrict and release the oviduct passageway, preferableadjusted from outside the patients body non-invasively.

It may also be adjusted by manual manipulation or adapted to be adjustedby electrical or magnetic power or adapted to be adjusted by hydraulicpower. The hydraulic power may comprising at least one subcutaneouslyplaced reservoir controlled by the patient.

The restriction device may of course preferable be adapted to beadjusted reversible.

The system is adapted to provide a restriction to accumulate at leastone egg released from the ovary in the oviduct for a predeterminedperiod of time, and releasing the restriction when convenient for thepatient to increase the likelihood to get pregnant. The predeterminedperiod of time is adapted to be between 0 and 2 days repeated very monthuntil pregnancy is achieved or preferable a predetermined period between8 and 12 hours.

All embodiments and features described below may if possible be used forboth, be adapted to be used with the apparatus, and being used with anyof the methods described below.

Flow Restriction

The device of the present invention is well suited for the controllingthe flow of eggs into the uterus of a female patient. Basically thedevice could be performed in eight different principle ways:

Hydraulic restrictions,

Mechanical restrictions,

Combination of any hydraulic or mechanical restriction device with astimulation device for restricting, and

Stimulation device alone,

Vary the restriction area. Any of these in any combination could be usedto over time vary the restriction area of the oviduct from one portionto another one and later back again. Several different areas could beinvolved in such a system to vary the restriction portion/area. Thiswould allow the oviduct to recover the restricted area still keeping therestriction over a longer period.

Using a moving device. When the restriction area being moved betweendifferent areas, specially when the restriction is moved upstreamtowards the ovary, it may be convenient to use a moving device, to avoidany egg being squeezed in a new upstream restriction area and by mistakebeing released for further downstream transportation when therestriction being released and moved further upstream. The moving devicemay be adapted to create a movement of the oviduct wall to create amovement of any egg placed in the new upcoming restricted area. Thiscould be caused by any of the above mentioned restriction devices,mechanical, hydraulic or stimulation device alone or in any combination,but may also be a separate device which also may be a mechanical, ahydraulic or a stimulation device. In one embodiment the moving devicecause vibrations.

Peristaltic like wave movement of the oviduct wall towards the ovary.Another principle is to stop the egg reaching the uterus by creatingperistaltic wave like movements of the oviduct wall.

Such peristaltic wave like movements upstream direction towards theovary may stop flow of any egg towards the uterus without fullyrestricting the oviduct to allow any sperm to pass and also

Peristaltic like wave movement of the oviduct wall towards the uterus bybeing able to cause movement of the egg down to uterus with a downstream peristaltic wave.

Thus both a method for controlling the flow in the lumen and anapparatus adapted to control the flow in the lumen may be implementedaccording to different embodiments and features in any combinationdescribed in this document.

d) Stimulation device alone, which could both 1) restrict by stimulationand 2) also creating peristaltic wave like movements to if a) upstreamstop flow without fully restricting the oviduct and also b) being ableto cause movement of the egg down to uterus with a down streamperistaltic wave:

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the device restricts the wall portion, andthe control device controls the stimulation device to intermittently andindividually stimulate the areas of the wall portion. This intermittentand individual stimulation of different areas of the wall portion of theoviduct allows tissue of the wall portion to maintain substantiallynormal blood circulation during the operation of the apparatus of theinvention.

The stimulation of different areas may be used both for closing thelumen in a safe way but also be used for creating a peristaltic wave inthe oviduct.

Movement of the Egg in the Oviduct Lumen

In one embodiment the device is adapted to constrict the wall portion torestrict or vary the flow in the lumen, and the control device controlsthe stimulation device to progressively stimulate the constricted wallportion, in the downstream or upstream direction of the lumen, to causeprogressive contraction of the wall portion to move the egg downstreamsin the lumen or prevent further transport down of the egg to the uterus.

Sensor

The control device may control the stimulation device to change thestimulation of the wall portion in response to a sensed physicalparameter of the patient or functional parameter of the device. Forexample, the control device may control the stimulation device toincrease the intensity of the stimulation of the wall portion inresponse to a sensed pressure increase in the oviduct, such that theflow in the oviduct remains stopped. Any sensor for sensing a physicalparameter of the patient, such as a pressure in the patient's body thatrelates to the pressure in the oviduct may be provided, wherein thecontrol device controls the stimulation device in response to signalsfrom the sensor. Such a sensor may for example sense the pressure in thepatient's abdomen, the pressure against the implanted constrictiondevice or the pressure on the tissue wall of the bodily organ.

For example, a hormone level sensor may be applied where the presentinvention is used for controlling flow of the egg.

More than One Restriction Area

The restriction device independent of which type or combination of typespreferable comprises a more than one restriction area being adapted tochange the restriction area over time. This will prevent any damage tothe oviduct still keeping the oviduct closed avoiding any egg to pasdown to the uterus thus avoiding pregnancy.

In one embodiment the system comprising a hydraulic restriction devicewith two or more restriction areas connected individually to two or morereservoirs with hydraulic fluid, said reservoirs adapted to be regulatedto move fluid from said reservoirs individually to each of the connectedrestriction areas. It is possible to use only one reservoir if valvesinstead control to which restriction the hydraulic fluid is acting on.

The hydraulic restriction areas is adapted to be restricted for apredetermined time period preferable with some overlap in time andadapted to first restrict the restriction area closest to the ovary thenchanging restriction area towards the uterus. This way the restrictionmay all the time be kept but without risking to have any egg to pas whenchanging restriction area both because of the overlap in restriction andalso because restriction is started first closest to the ovary where theegg is released.

The hydraulic restriction areas may be adapted to be regulated by manualmanipulation thereof.

The system may also be adapted to have the changes of the restrictionarea cause a peristaltic wave like restriction wave in the directiontowards the ovary to prevent the egg being transported down to theuterus. This peristaltic wave may be caused by any of the differenttypes of restriction devices or combinations described earlier. Thiswave could prevent the egg being transported down to the uterus alsowithout fully restricting the oviduct. This would then allow the spermto reach the egg during the accumulation period of a few days, thusincreasing likelihood of pregnancy even further.

The restriction device may also be adapted to effect a transport of theat least one egg to the uterus upon release of the oviduct. This may bewith a peristaltic wave like restriction wave in the opposite directiontowards the uterus.

A system of increasing likelihood of pregnancy may be adapted torestrict a first part or area of an oviduct of the patient to provide arestriction to accumulate at least one egg released from the ovary inthe oviduct for a predetermined period of time, and adapted to restricta second part of the oviduct and thereafter release the restriction ofthe first part and also later release the restriction of the secondpart, thereby allow transport of the egg down to the uterus or thesystem may further be adapted to also restrict a third part of theoviduct and release the restriction of the second part also it mayfurther be adapted to release the restriction of the third part therebyallow transport of the egg down to the uterus or the system may beadapted to restrict a fourth part of the oviduct

and release the restriction of the third part. Finally it may be furtheradapted to release the restriction of the fourth part, thereby allowtransport of the egg down to the uterus.

The number of restriction areas has no limit except practical sizeissues and the restriction time period is preferable divided between therestriction areas. Either the restriction area is moved from the ovaryand further down towards the uterus step by step thus avoiding anyinterference with any accumulated egg being involved in any restrictionarea if a certain overlap in time is fulfilled between the consecutiverestriction areas in use or the restriction areas are moved both up- anddown-stream then preferable using a movement device to move the egg inthe oviduct to avoid any egg being squeezed in any restriction area whenrestriction are moved towards the ovary or having the peristaltic likewave moving towards the ovary keeping the egg accumulated in the oviductwithout fully restricting the same.

Preferable a hydraulic restriction device only partly restricting theoviduct is used maybe in combination with a stimulation device to causethe peristaltic wave in the oviduct. With the stimulation device it isthen possible to move the restriction area. The hydraulic device may forexample have the movement function to cause the movements necessary.

Any combination is possible of mechanical, hydraulic or stimulationdevice or separate use of the same.

In summary preferable more than two restricting areas is used andvarying the restricting area while at least one restricting area isclosed when the device being in restriction mode.

If the device is adapted to restrict the first part of the oviductclosest to the ovary it will allow the second restriction beingrestricted without interfering with any accumulated egg.

There are no limit how many areas could be restricted except practicaland size issues.

Moving in restriction from the ovary and down towards the uterus is thenthe preferred way of doing it, for example three restrictions couldshare a time period of three days with one day each to not risking to inany way damage the oviduct,

A system adapted to restrict the restriction areas in consecutive orderstarting with the restriction area, part of the oviduct, closest to theovary and thereafter restrict any new area one step closer to the uterusand further adapted to overlap in time the restriction of more than onerestriction area will allow to restrict without interfering with anyaccumulated egg.

Peristaltic Like Wave Oviduct Wall Movements

The restriction device may be adapted to only partly restrict theoviduct and to create peristaltic wave like movements of a part of theoviduct(s) wall to prevent the transport of an egg in an oviduct to theuterus of the human or mammal patient, and therefore accumulate at leastone egg released from the ovary in the oviduct for a predeterminedperiod of time, and wherein the sperm is able to reach the egg duringthe time the egg is accumulated because the oviduct is only partlyrestricted, and the restriction device further adapted to release theegg, controlled from outside the body, to allow the at least on egg inthe oviduct a transport to the uterus.

The device is then preferable adapted to comprise at least onerestricted area adapted to at least partly restrict and change therestriction area over time most likely adapted to comprise two or morerestricted areas adapted to at least partly restrict different portionsof the oviduct and change the restriction area over time.

The change of the restriction area may be adapted to cause a peristalticwave like wave in the direction towards the ovary to prevent the eggbeing transported down to the uterus.

The restriction device may comprise a hydraulic device or a mechanicaldevice or a stimulation device adapted to cause said peristaltic wavelike restriction wave.

The device is adapted to allow a transport of the at least one egg tothe uterus upon release of the oviduct and may even cause a anotherperistaltic wave like restriction wave in the opposite direction towardsthe uterus.

The device is adapted to be adjusted which could be done by manualmanipulation or electrical or magnetic power.

The restriction areas is only partly restricted to allow the sperm toreach the egg and the device adapted to prevent the egg to temporaryreach the uterus with the peristaltic wave, to accumulate the eggtemporary in the oviduct to allow increased likelihood for pregnancy toprolong the time period the egg being reachable by the sperm.

When the restriction areas is completely restricted to prevent the eggto temporary reach the uterus, the timing of the release of the egg iscrucial after having accumulated the egg temporary in the oviduct thewhole procedure to allow increased likelihood for pregnancy whenreleased.

The restriction device is adapted to and intended to repeatedly everymonth repeat the post-operational and non-invasive regulation of thedevice actively reversible to prevent transport of an egg from the ovaryto the uterus in the oviduct of the patient and reverse the function byallowing the normal transport of the egg from the ovary to the uterusuntil pregnancy has been achieved.

The device may comprise a mechanical device or a hydraulic device or astimulation device adapted to cause said peristaltic like wave towardsthe ovary.

Restriction Embodiments

The restriction device may comprises a mechanical restriction device ora hydraulic restriction device or a stimulation device or a stimulationdevice in combination with a mechanical or hydraulic restriction deviceor any other combination.

The method may include a hydraulic restriction device comprising areservoir, for moving gas or fluid to or from said restriction deviceand wherein said reservoir is placed subcutaneously for being reached bythe patients hand for moving fluid manually to or from said restrictiondevice. Preferable two or more reservoirs could be used for restrictingdifferent areas, starting with the area closest to the ovary.

Movement Device

The movement device is adapted to move the egg out of a varied upcomingnew restricted area before a new area is restricted useful if therestriction need to be moved also in the direction towards the ovary inwhich case the egg could slip through if being squeezed by onerestriction area and later released.

The movement device may be the same device as the restriction device,adapted to work differently when restricting or causing movements of theegg or it may be a different device as the restriction device adapted towork differently when restricting or causing movements of the egg.

The movement device may cause vibration or wave like movements in theoviduct wall thereby causing movements of the egg.

-   -   Further Method

A method of promoting pregnancy of a female mammal or human patient, maycomprise the following steps:

restricting an oviduct of the patient postoperatively to provide arestriction to accumulate at least one egg released from the ovary inthe oviduct for a predetermined period of time, and

releasing the restriction to admit any egg in the oviduct a transport tothe uterus

controlling the restricting and releasing procedures from outside thepatients body.

-   -   In this and other methods the predetermined period of time is        adapted to avoid pregnancy and may be between 0 and 2 days or        preferable 8-12 hours.    -   A method for placing and controlling two implanted restriction        devices promoting pregnancy in a human or mammal patient, the        method comprising the steps of:

inserting a needle like tube into the abdomen of the patients body,

using the tube like needle like to fill the abdomen with gas therebyexpanding the abdominal cavity,

placing at least two laparoscopic trocars in the patient's body,

inserting a camera through one of the trocars into the abdomen,

inserting at least one dissecting tool through a trocar and dissectingan area of at least one portion of the two oviducts of the patient,

placing two implanted restriction devices, on each of the two oviducts

adjusting the restriction devices after the operation at a timeconvenient to get pregnat thus,

controlling the adjustment from outside the patients body and

post-operatively restricting and releasing the two oviducts to increasethe likelihood of getting pregnant.

Both methods above could when restricting the oviduct comprising thefollowing steps:

restricting a first part or area of an oviduct of the patient to providea restriction to accumulate at least one egg released from the ovary inthe oviduct for a predetermined period of time, and

restricting a second part of the oviduct

releasing the restriction of the first part

allowing the oviduct shorter restriction periods at each restrictionarea.

May also comprise the steps of:

releasing the restriction of the second part

allowing transport of the egg down to the uterus

May also comprise the steps of:

restricting a third part of the oviduct

releasing the restriction of the second part

allowing the oviduct shorter restriction periods at each restrictionarea.

May also comprise the steps of:

releasing the restriction of the third part

allowing transport of the egg down to the uterus

May also comprise the steps of:

restricting a fourth part of the oviduct

releasing the restriction of the third part

allowing the oviduct shorter restriction periods at each restrictionarea.

May also comprise the steps of:

releasing the restriction of the fourth part

allowing transport of the egg down to the uterus

In both these methods normally if the restricted first part of theoviduct being closer to the ovary this is.

allowing the second restriction being restricted without interferingwith any accumulated egg.

Normally these methods,

having more than two restricting areas and

varying the restricting area while

keeping at least one restricting area closed when restriction beingwished

In a preferred embodiment;

the restriction areas being restricted in consecutive order startingwith the restriction area, part of the oviduct, closest to the ovarythereafter

restricting any new area one step closer to the uterus

overlapping in time the restriction of more than one restriction areathereby,

restricting without interfering with any accumulated egg

A method may of course only include independent of order varying therestriction area postoperatively to allow the oviduct to recover oravoid any damage from the restriction while

keeping the oviduct restricted.

Another method of promoting pregnancy of a female patient, comprisingthe following steps:

preventing the transport of an egg in an oviduct to the uterus of thehuman or mammal patient,

accumulating at least one egg released from the ovary in the oviduct fora predetermined period of time, by

casing a peristaltic like restriction wave movement of a part of theoviduct(s) wall preventing the egg being transported down to the uteruswhile only partly restricting the oviduct, and

allowing the spermie to reach the egg during the time the egg isaccumulated, and

releasing the egg post-operatively controlled from the outside the humanbody to admit the at least on egg in the oviduct to allow a transport ofthe at least one egg to the uterus.

A method for placing the device above and controlling the implanteddevice promoting pregnancy in a human or mammal patient, the methodcomprising the steps of:

inserting a tube like needle into the abdomen of the patients body,

using the tube like needle like to fill the abdomen with gas therebyexpanding the abdominal cavity,

placing at least two laparoscopic trocars in the patient's body.

inserting a camera through one of the trocars into the abdomen,

inserting at least one dissecting tool through a trocar and dissectingan area of at least one portion of the two oviducts of the patient,

placing two parts of the implanted device, one each on the two oviducts

finishing the operation and withdrawing the instruments after eventualsuturing and thereafter postoperatively:

adjusting the device after the operation at a time relevant to getpregnat,

controlling the adjustment from outside the patients body and thereby

casing a peristaltic like wave movement of a part of the oviduct(s) walltowards the ovary preventing the egg being transported down to theuterus without fully restricting the oviduct, thereby

preventing flow of any egg to reach the uterus in the two oviducts for apredetermined period of time and thereby

accumulating any egg released from the ovary in the oviduct(s) by

allowing the spermie to reach the egg during the time the egg isaccumulated

releasing any egg in the oviduct from outside the body to allow the eggto in a normal way be transported down to the uterus.

Movement Method

Another method of preventing pregnancy of a female human or mammalpatient may be provided, comprising the following steps:

restricting a first part of an oviduct of the patient to provide arestriction to accumulate at least one egg released from the ovary inthe oviduct for a predetermined period of time, and

moving the accumulated egg by said movement device away in the oviducttowards the ovary from the restriction area,

allowing a second part of the oviduct closer to the ovary beingrestricted without interfering with any accumulated egg

releasing the restriction of the first part

repeating the restriction of the first part

releasing the restriction of the second part

allowing the oviduct to recover between restriction intervals.

Preferably followed by;

repeating moving any accumulated egg by said movement device away in theoviduct towards the ovary from the restricted first area, repeating

allowing a second part of the oviduct closer to the ovary beingrestricted without interfering with any accumulated egg, furtherrepeating

releasing the restriction of the first part

repeating the complete procedure allowing the oviduct to recover betweenrestriction intervals.

Preferable also the restriction areas is adapted to be varied betweenthree or more areas always keeping the oviduct closed.

Said movement device may comprise a vibrating device, for causing avibration of at least a part of the wall of said oviduct causingmovement of any accumulated egg, said movement being repeated.

Said movement device may comprise a mechanical device or a hydraulicdevice or a stimulation device or a combined device.

Pregnancy Inhibition

The object of the present invention is to provide a system and a methodfor pregnancy control of a female patient.

The inventive system allows the egg from the ovary to be retained in theoviduct to avoid pregnancy. A restriction device is placed on the twooviducts to restrict and release the oviduct, thereby effecting theabove mentioned retaining of the egg.

In accordance with a first aspect of the present invention, there isprovided a system for treating a female patient to avoid pregnancycomprising a restriction device adapted to postoperatively restrict andrelease an oviduct of the patient.

In accordance with a second aspect of the invention, there is provided amethod of avoiding pregnancy of a female patient, comprising the stepsof restricting an oviduct of the patient to provide a restriction toaccumulate at least one egg released from the ovary in the oviduct for apredetermined period of time, and releasing the restriction to admit theat least on egg in the oviduct to be transported to the uterus.

All embodiments and features described below may if possible be used forboth, be adapted to be used with the apparatus, and being used with anyof the methods described below.

A system for treating a female patient to avoid pregnancy comprising: arestriction device adapted to postoperatively restrict and release anoviduct of the patient.

The restriction device is preferably adapted to provide a restriction ofthe oviduct to accumulate at least one egg released from the ovary inthe oviduct.

The restriction device may be adapted to provide a release of theoviduct only when pregnancy is wanted or not possible.

The restriction device may be adapted to be adjusted from outside thepatients body to restrict and release the oviduct passageway, preferableadjusted from outside the patients body non-invasively.

It may also be adjusted by manual manipulation or adapted to be adjustedby electrical or magnetic power or adapted to be adjusted by hydraulicpower. The hydraulic power may comprising at least one subcutaneouslyplaced reservoir controlled by the patient.

The restriction device may of course preferable be adapted to beadjusted reversible.

The system is adapted to provide a restriction to accumulate at leastone egg released from the ovary in the oviduct for a predeterminedperiod of time, and releasing the restriction when convenient for thepatient to avoid pregnancy. The predetermined period of time is adaptedto avoid pregnancy and may be between 1 and 30 days or a predeterminedperiod of time more than 30 days.

Flow Restriction

The system of the present invention is well suited for the controllingthe flow of eggs into the uterus of a female patient. Basically therestriction device could be performed in eight different principle ways:

Hydraulic restrictions

Mechanical restrictions

Combination of any hydraulic or mechanical restriction device with astimulation device for restricting.

Stimulation device alone for restricting.

-   -   Vary the restriction area. Any of these in any combination could        be used to over time vary the restriction area of the oviduct        from one portion to another one and later back again. Several        different areas could be involved in such a system to vary the        restriction portion/area. This would allow the oviduct to        recover the restricted area still keeping the restriction over a        longer period.    -   a moving device. When the restriction area being moved between        different areas, specially when the restriction is moved        upstream towards the ovary, it may be convenient to use a moving        device, to avoid any egg being squeezed in a new upstream        restriction area and by mistake being released for further        downstream transportation when the restriction being released        and moved further upstream. The moving device may be adapted to        create a movement of the oviduct wall to create a movement of        any egg placed in the new upcoming restricted area. This could        be caused by any of the above mentioned restriction devices,        mechanical, hydraulic or stimulation device alone or in any        combination, but may also be a separate device which also may be        a mechanical, a hydraulic or a stimulation device. In one        embodiment the moving device cause vibrations.    -   like wave movement of the oviduct wall towards the ovary.        Another principle is to stop the egg reaching the uterus by        creating peristaltic like wave movements of the oviduct wall.

Such peristaltic like wave movement in the upstream direction towardsthe ovary may stop flow of a egg towards the uterus preferable alwaysfully restricting some part of the oviduct to avoid any spermie to pasand also

-   -   Peristaltic like wave movement of the oviduct wall towards the        uterus. Another principle is to promote the egg reaching the        uterus by being able to cause movement of the egg down to uterus        with a down stream peristaltic wave when risk of pregnancy do        not occur.        The areas will be outlined below:        Hydraulic Restriction

Where the operation device hydraulically operates the constrictiondevice of the restriction or combined restriction/stimulation unit (d),it includes hydraulic means for adjusting the restriction device.

In an embodiment of the invention, the hydraulic means comprises areservoir and an expandable/contractible cavity in the constrictiondevice, wherein the operation device distributes hydraulic fluid fromthe reservoir to expand the cavity, and distributes hydraulic fluid fromthe cavity to the reservoir to contract the cavity. The cavity may bedefined by a balloon of the constriction device that abuts the tissuewall portion of the patient's organ, so that the patient's wall portionis constricted upon expansion of the cavity and released uponcontraction of the cavity.

Alternatively, the cavity may be defined by a bellows that displaces arelatively large contraction element of the constriction device, forexample a large balloon that abuts the wall portion, so that thepatient's wall portion is constricted upon contraction of the bellowsand released upon expansion of the bellows. Thus, a relatively smalladdition of hydraulic fluid to the bellows causes a relatively largeincrease in the constriction of the wall portion. Such a bellows mayalso be replaced by a suitably designed piston/cylinder mechanism.

Where the hydraulic means comprises a cavity in the constriction device,the apparatus of the invention can be designed in accordance with theoptions listed below.

1) The reservoir comprises first and second wall portions, and theoperation device displaces the first and second wall portions relativeto each other to change the volume of the reservoir, such that fluid isdistributed from the reservoir to the cavity, or from the cavity to thereservoir.

1a) The first and second wall portions of the reservoir are displaceablerelative to each other by at least one of a magnetic device, a hydraulicdevice or an electric control device.

2) The apparatus comprises a fluid conduit between the reservoir and thecavity, wherein the reservoir forms part of the conduit. The conduit andreservoir and apparatus are devoid of any non-return valve. Thereservoir forms a fluid chamber with a variable volume, and distributesfluid from the chamber to the cavity by a reduction in the volume of thechamber and withdraws fluid from the cavity by an expansion of thevolume of the chamber. The apparatus further comprises a motor fordriving the reservoir, comprising a movable wall of the reservoir forchanging the volume of the chamber.

In a special embodiment of the invention, the operation device comprisesa reverse servo operatively connected to the hydraulic means. The term“reverse servo” is to be understood as a mechanism that transfers astrong force acting on a moving element having a short stroke into aweak force acting on another moving element having a long stroke; i.e.,the reverse function of a normal servo mechanism. Thus, minor changes inthe amount of fluid in a smaller reservoir could be transferred by thereverse servo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operationthereof.

Preferable a manually operated reservoir could be placed subcutaneouslyfor manual manipulation thereof.

Mechanical Restriction

Where the operation device mechanically operates the restriction deviceor the restriction/stimulation unit (d), it may be non-inflatable.Furthermore, the operation device may comprise a servo system, which mayinclude a gearbox. The term “servo system” encompasses the normaldefinition of a servo mechanism, i.e., an automatic device that controlslarge amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a weak force acting on a moving element having a longstroke into a strong force acting on another moving element having ashort stroke. Preferably, the operation device operates the constrictiondevice in a non-magnetic and/or non-manual manner. A motor may beoperatively connected to the operation device. The operation device maybe operable to perform at least one reversible function and the motormay be capable of reversing the function.

Combination of Mechanical or Hydraulic Restriction Device and aStimulation Device

The present invention provides an advantageous combination ofrestriction and stimulation devices, which results in a two-stageinfluence on the flow of eggs in the lumen of the oviduct. Thus, theconstriction device may gently constrict the tissue wall of the oviductwall by applying a relatively weak force against the wall portion, andthe stimulation device may stimulate the constricted wall portion toachieve the desired final influence on the flow in the lumen. The phrase“gently constricting a portion of the tissue wall” is to be understoodas restricting the wall portion without substantially hampering theblood circulation in the tissue wall.

In accordance with a first flow restriction option, the control devicecontrols the constriction device to constrict the wall portion, suchthat flow in the lumen is restricted or stopped, and controls thestimulation device to stimulate the constricted wall portion to causecontraction thereof, such that flow in the lumen is further restrictedor more safely stopped. More precisely, a control device may control thestimulation device in a first mode to stimulate the constricted wallportion to further restrict or stop the flow in the lumen and to:

a) control the stimulation device in a second mode to cease thestimulation of the wall portion to increase the flow in the lumen; or

b) control the stimulation and constriction devices in the second modeto cease the stimulation of the wall portion and release the wallportion to restore the flow in the lumen.

Thus both a method for controlling the flow in the lumen and anapparatus adapted to control the flow in the lumen may be implementedaccording to different embodiments and features in any combinationdescribed in this document.

d) Stimulation device alone, which could both 1) restrict by stimulationand 2) also creating peristaltic wave like movements to if a) upstreamstop flow without fully restricting the oviduct and also b) being ableto cause movement of the egg down to uterus with a down streamperistaltic wave:

Preferably, the stimulation device is adapted to stimulate differentareas of the wall portion as the restriction device restricts the wallportion, and the control device controls the stimulation device tointermittently and individually stimulate the areas of the wall portion.This intermittent and individual stimulation of different areas of thewall portion of the oviduct allows tissue of the wall portion tomaintain substantially normal blood circulation during the operation ofthe apparatus of the invention.

The stimulation of different areas may be used both for closing thelumen in a safe way but also be used for creating a peristaltic wave inthe oviduct.

Movement of the Ea in the Oviduct Lumen

In one embodiment the restriction device is adapted to constrict thewall portion to restrict or vary the flow in the lumen, and the controldevice controls the stimulation device to progressively stimulate theconstricted wall portion, in the downstream or upstream direction of thelumen, to cause progressive contraction of the wall portion to move theegg downstreams in the lumen or prevent further transport down of theegg to the uterus.

More than One Restriction Area

The restriction device is independent of which type or combination oftypes preferable. It comprises more than one restriction area, therebybeing adapted to change the restriction area over time. This willprevent any damage to the oviduct still keeping the oviduct closedavoiding any egg to pas down to the uterus thus avoiding pregnancy.

I one embodiment the system comprises a hydraulic restriction devicewith two or more restriction areas connected individually to two or morereservoirs with hydraulic fluid, said reservoirs adapted to be regulatedto move fluid from said reservoirs individually to each of the connectedrestriction areas. It is possible to use only one reservoir if valvesinstead control on which restriction the hydraulic fluid is acting.

The hydraulic restriction areas are adapted to be restricted for apredetermined time period, preferably with some overlap in time andadapted to first restrict the restriction area closest to the ovary andthen changing restriction area towards the uterus. This way therestriction may all the time be kept but without risking to have any eggto pass when changing restriction area both because of the overlap inrestriction and also because restriction is started first closest to theovary where the egg is released.

The hydraulic restriction areas may be adapted to be regulated by manualmanipulation thereof.

The system may also be adapted to that the change of the restrictionarea cause a peristaltic wave like restriction wave in the directiontowards the ovary to prevent the egg being transported down to theuterus. This peristaltic wave may be caused by any of the differenttypes of restriction devices or combinations discribed earlier.

The restriction device may also be adapted to effect a transport of theat least one egg to the uterus upon release of the oviduct. This may bewith a peristaltic wave like restriction wave in the opposite directiontowards the uterus.

A system of preventing pregnancy may be adapted to restrict a first partor area of an oviduct of the patient to provide a restriction toaccumulate at least one egg released from the ovary in the oviduct for apredetermined period of time, and adapted to restrict a second part ofthe oviduct and thereafter release the restriction of the first part andalso later release the restriction of the second part, thereby allowtransport of the egg down to the uterus or the system may further beadapted to also restrict a third part of the oviduct and release therestriction of the second part also it may further be adapted to releasethe restriction of the third part thereby allow transport of the eggdown to the uterus or the system may be adapted to restrict a fourthpart of the oviduct and release the restriction of the third part.Finally it may be further adapted to release the restriction of thefourth part, thereby allow transport of the egg down to the uterus.

The number of restriction areas has no limit except for practical sizeissues and the restriction time period is preferably divided between therestriction areas. Either the restriction area is moved from the ovaryand further down towards the uterus step by step thus avoiding anyinterference with any accumulated egg being involved in any restrictionarea if a certain overlap in time is fulfilled between the consecutiverestriction areas in use or the restriction areas are moved both up- anddown-stream then preferable using movement device to move the egg in theoviduct to avoid any egg being squeezed in any restriction area.

Preferably a hydraulic restriction device only partly restricting theoviduct is used in combination with a stimulation device to completelyclose the oviduct. With the stimulation device it is then possible tomove the restriction area. The hydraulic device may for example have themovement function to cause the movements necessary.

Any combination possible.

In summary preferably more than two restricting areas are used andvarying the restricting area while at least one restricting area isclosed when the device being in restriction mode.

If the device is adapted to restrict the first part of the oviductclosest to the ovary it will allow the second restriction beingrestricted without interfering with any accumulated egg.

A system adapted to restrict the restriction areas in consecutive orderstarting with the restriction area, part of the oviduct, closest to theovary and thereafter restrict any new area one step closer to the uterusand further adapted to overlap in time the restriction of more than onerestriction area will allow to restrict without interfering with anyaccumulated egg.

A method of avoiding pregnancy of a female mammal or human patientcomprises the following steps:

restricting an oviduct of the patient postoperatively to provide arestriction to accumulate at least one egg released from the ovary inthe oviduct for a predetermined period of time,

releasing the restriction to admit any egg in the oviduct a transport tothe uterus, and

controlling the restricting and releasing procedures from outside thepatients body.

In this and other methods the predetermined period of time is adapted toavoid pregnancy and may be between 2 and 30 days or more than 30 days.

A method for placing and controlling two implanted restriction devicesavoiding pregnancy in a human or mammal patient comprises the steps of:

inserting a needle or tube like instrument into the abdomen of thepatients body,

using the needle or tube like instrument to fill the abdomen with gasthereby expanding the abdominal cavity,

placing at least two laparoscopic trocars in the patient's body,

inserting a camera through one of the trocars into the abdomen.

inserting at least one dissecting tool through a trocar and dissectingan area of at least one portion of the two oviducts of the patient,

placing two implanted restriction devices, on each of the two oviducts

adjusting the restriction devices after the operation at a timeconvenient to not get pregnat thus,

controlling the adjustment from outside the patients body and

post-operatively restricting the two oviducts to avoid getting pregnant

Both methods above could when restricting the oviduct comprising thefollowing steps:

restricting a first part or area of an oviduct of the patient to providea restriction to accumulate at least one egg released from the ovary inthe oviduct for a predetermined period of time,

restricting a second part of the oviduct,

releasing the restriction of the first part, and

allowing the oviduct shorter restriction periods at each restrictionarea.

The method may also comprise the steps of:

releasing the restriction of the second part, and

allowing transport of the egg down to the uterus.

The method may also comprise the steps of

restricting a third part of the oviduct,

releasing the restriction of the second part, and

allowing the oviduct shorter restriction periods at each restrictionarea.

The method may also comprise the steps of:

releasing the restriction of the third part, and

allowing transport of the egg down to the uterus.

The method may also comprise the steps of:

restricting a fourth part of the oviduct,

releasing the restriction of the third part, and

allowing the oviduct shorter restriction periods at each restrictionarea.

The method may also comprise the steps of:

releasing the restriction of the fourth part, and

allowing transport of the egg down to the uterus.

I both these methods, normally if the restricted first part of theoviduct is closer to the ovary this is,

allowing the second restriction being restricted without interferingwith any accumulated egg.

Normally these methods comprise

having more than two restricting areas and

varying the restricting area while

keeping at least one restricting area closed when restriction isdesired.

In a preferred embodiment, the restriction areas are restricted inconsecutive order starting with the restriction area, part of theoviduct, closest to the ovary thereafter,

restricting any new area one step closer to the uterus,

overlapping in time the restriction of more than one restriction areathereby

restricting without interfering with any accumulated egg

A method may only include, independently of order, varying therestriction area postoperatively to allow the oviduct to recover or toavoid any damage from the restriction while keeping the oviduct alwaysrestricted.

Another method of preventing pregnancy of a female patient comprises thefollowing steps:

preventing the transport of an egg in an oviduct to the uterus of thehuman or mammal patient,

accumulating at least one egg released from the ovary in the oviduct fora predetermined period of time, by

casing a peristaltic like restriction wave movement of a part of theoviduct(s) wall preventing the egg being transported down to the uteruswhile restricting the oviduct at all times,

preventing the spermie to reach the egg during the time the egg isaccumulated, and

releasing the egg post-operatively controlled from the outside the humanbody

to admit the at least on egg in the oviduct to allow a transport of theat least one egg to the uterus.

A method for placing the device above and controlling the implanteddevice avoiding pregnancy in a human or mammal patient comprises thesteps of:

inserting a needle or tube like instrument into the abdomen of thepatients body,

using the needle or tube like Instrument to fill the abdomen with gasthereby expanding the abdominal cavity,

placing at least two laparoscopic trocars in the patient's body,

inserting a camera through one of the trocars into the abdomen.

inserting at least one dissecting tool through a trocar and dissectingan area of at least one portion of the two oviducts of the patient,

placing two parts of the implanted device, one each on the two oviducts

finishing the operation and withdrawing the instruments after eventualsuturing and thereafter postoperatively:

adjusting the device after the operation at a time relevant to avoidgetting pregnat,

controlling the adjustment from outside the patients body and thereby

preventing flow of any egg to reach the uterus in the two oviducts for apredetermined period of time to avoid getting pregnant and thereby

accumulating any egg released from the ovary in the oviduct(s) by

casing a peristaltic like wave movement of a part of the oviduct(s) wallpreventing the egg being transported down to the uterus restricting theoviduct at all times,

preventing sperms from reaching the egg during the time the egg isaccumulated, and

releasing any egg in the oviduct from outside the body to allow the eggto in a normal way be transported down to the uterus when risk forpregnacy is low.

Restriction Embodiments

The restriction device may comprise a mechanical restriction device or ahydraulic restriction device or a stimulation device or a stimulationdevice in combination with a mechanical or hydraulic restriction deviceor any other combination.

The method may include a hydraulic restriction device comprising areservoir, for moving gas or fluid to or from said restriction deviceand wherein said reservoir is placed subcutaneously for being reached bythe patients hand for moving fluid manually to or from said restrictiondevice.

Method Movement Device

The movement device is adapted to move the egg out from a variedupcoming new restricted area before a new area is restricted useful ifthe restriction should be kept for a longer period of time and therestriction area therefore needs to be moved also in the directiontowards the ovary in which case the egg could slip through if beingsqueezed by one restriction area and later released.

The movement device may be the same device as the restriction device,adapted to work differently when restricting or causing movements of theegg or it may be a different device as the restriction device adapted towork differently when restricting or causing movements of the egg.

The movement device may cause vibration or wave like movements in theoviduct wall thereby causing movements of the egg.

Therefore another method of preventing pregnancy of a female human ormammal patient may be provided, comprising the following steps:

restricting a first part of an oviduct of the patient to provide arestriction to accumulate at least one egg released from the ovary inthe oviduct for a predetermined period of time, and

moving the accumulated egg by said movement device away in the oviducttowards the ovary from the restriction area.

allowing a second part of the oviduct closer to the ovary beingrestricted without interfering with any accumulated egg,

releasing the restriction of the first part,

repeating the restriction of the first part,

releasing the restriction of the second part,

allowing the oviduct to recover between restriction intervals.

These steps are preferably followed by;

repeating moving any accumulated egg by said movement device away in theoviduct towards the ovary from the restricted first area, repeating

allowing a second part of the oviduct closer to the ovary beingrestricted without interfering with any accumulated egg, furtherrepeating,

releasing the restriction of the first part,

repeating the complete procedure allowing the oviduct to recover betweenrestriction intervals.

Preferably also the restriction areas are adapted to be varied betweenthree or more areas while always keeping the oviduct closed.

Said movement device may comprise a vibrating device, for causing avibration of at least a part of the wall of said oviduct causingmovement of any accumulated egg, said movement being repeated.

Said movement device may comprise a mechanical device or a hydraulicdevice or a stimulation device or a combined device.

Temporary Male Contraception

The object of the present invention is to provide a temporary malecontraception apparatus.

In accordance with this object, there is provided a male contraceptionapparatus for obtaining temporary sterility of a male mammalianindividual comprising an implantable restriction device configured torestrict the patient's vas deference in the region downstream theampulla during a controlled period, the restriction device thereby beingcapable of preventing sperms to reach the urethra, and a control deviceoperable to control the operation of the restriction device.

The restriction device may comprise a hydraulic or mechanicalconstriction device as well as a stimulation device for, independentlyor together in any combination, temporarily restrict vas deferens.

In this context restriction of vas deference means that this lumen isoccluded in a manner to prevent sperms to reach the urethra by operatingon vas deference from the outside. The terms “vas deference” may includeone vas deference or both vase deferentia. When explaining thecontrolled restriction of vas deference according to the invention alsoother terms like “lumen” or “tissue portion” or “body organ” are used,but such terms shall be regarded as functional synonyms. The term“ampulla” refers to the enlargement of vas deference close to where itmeets the seminal vesicle.

The term “downstream the ampulla” refers to a location after the ampullain the direction of the urethra and the seminal vesicle. Consequently,“upstream the ampulla” would refer to a location on the vas deferencebefore the ampulla in the direction towards the testicle. That therestriction device is adapted to restrict vas deference in this specificregion preferably means that it is designed to be accommodated in thisregion of the body.

By accomplishing a restriction of vas deference downstream of theampulla, the presently invented apparatus admits a reliable temporarysterilization by shielding of sperms compartmentalized in the ampulla,whereby the apparatus immediately may exert its contraceptive effect.Even if the principal utility of the apparatus is to prevent spermtransport for a controlled, temporary period, for example during sexualintercourse by activating the restriction device, certain embodiments ofthe invention also admits support of transporting sperms through vasdeference to assist individuals having impairments in thistransportation system. Advantageously, the present invention admits avery limited time period the restriction needs to be restricted.Existing treatments need to be closed at least 5 days before it is safe,the life time of a sperm, thus risking damaging vas deferens.Furthermore, the apparatus prevents from that sperms accumulate in thevas deferens due to long term restriction which may lead to undesiredcomplications.

The restriction device is very carefully be adapted to the specificposition downstream the ampulla. The amount of space is limited and therequirements are specific to allow placement in this region between theprostate and the ampulla of vas deferens. Because the ampulla comprisesa reservoir of sperm the restriction is performed in the downstreamregion to prevent any possibility to sperm reaching the urethra duringintercourse. The restriction device according to invention can also whenrelevant be adapted to accomplish restriction of closely located outletduct of seminal vesicles. A simultaneous restriction of this outlet ductshould be regarded as one of the effects obtainable with the presentInvention.

According to one embodiment of the invention, restriction devicecomprises a constriction device for constricting at least one portion ofa tissue wall of vas deference downstream the ampulla to stop the flowin the vas deference. For this purpose, the apparatus comprises anadjustable restriction device and an operation device for mechanicallyor hydraulically operating the adjustable restriction device to changethe restriction of a wall portion of vas deference. The operation devicepreferably operates the restriction device in a non-magnetic and/ornon-manual manner. Preferably, the operation device comprises anelectrically powered operation device, such as motor or a servo system.The term “servo system” means that the system includes a mechanism thattransfers a weak force acting on a moving element having a long strokeinto a strong force acting on another moving element having a shortstroke. According to one alternative the restriction device comprises aconstriction device comprising at least two elongated clamping elementsextending along the organ in the direction of flow in the patient's vasdeference on different sides of the organ, and the operation deviceoperates the clamping elements to clamp the wall portion between theclamping elements to constrict the wall portion. The operation devicecan alternatively comprise hydraulic means for hydraulically adjustingthe restriction device and a reverse servo operatively connected to thehydraulic means. The term “reverse servo” is to be understood as amechanism that transfers a strong force acting on a moving elementhaving a short stroke into a weak force acting on a moving element witha long stroke. Preferably, the reverse servo comprises at least twoimplantable reservoirs comprising hydraulic fluid, and preferably afirst reservoir is a subcutaneously implantable regulation reservoir.The reverse servo further comprises a second implantable servo reservoirwhich preferably is in fluid connection with the regulation reservoir.In one embodiment the second servo reservoir directly controls theexpansion/contraction of the constriction device. In another embodiment,the servo reservoir indirectly controls the expansion/contraction of theconstriction device, wherein the reverse servo further comprising athird reservoir adapted to be implanted in the abdomen orretroperitoneum or pelvic region and being operatively connected to thesecond servo reservoir for displacing hydraulic fluid of said thirdreservoir to operate the constriction device. Suitably, the thirdreservoir has a larger volume than the first reservoir. The thirdreservoir can be in fluid connection with the constriction device andthe servo reservoir can control the third reservoir with a mechanicalinterconnection

Alternatively, the restriction device comprises a non-inflatablemechanical constriction device and the operation device compriseshydraulic means that hydraulically adjusts the mechanical constrictiondevice.

According to another embodiment of the invention, the restriction devicecomprises a stimulation device for stimulating a wall portion of thetissue wall of vas deference in the region downstream the ampulla tocontract said wall portion to influence the flow in vas deference. Acontrol device controls the stimulation device to stimulate the wallportion and the control device is preferably operable from outside thepatient's body to control an implantable source of energy to releaseenergy for use in connection with the stimulation. The stimulationdevice is adapted to stimulate different areas of the wall portion andthe control device controls the stimulation device to intermittently andindividually stimulate the areas of the wall portion. This intermittentand individual stimulation of different areas of the wall portion of theorgan allows tissue of the wall portion to maintain substantially normalblood circulation during the operation of the apparatus of theinvention. Various alternatives of accomplishing restriction bystimulation and useful components are described below.

It is also an embodiment of the invention that restriction devicecomprises a mechanically or hydraulically operated constriction asdescribed above and a stimulation device as described above. The controldevice is adapted to control the constriction device and the stimulationdevice to in combination restrict vas deference.

The invention also embodies a method of stimulating the ampullacomprising employing an apparatus as described having a stimulationdevice for restricting vas deference downstream the ampulla. Acounterflow stimulation of the ampulla is thereby obtainable.

Further the invention comprises a system including any apparatusdescribed in previous sections. In a preferred embodiment, the systemcomprises at least one switch implantable in the patient for manuallyand non-invasively controlling the apparatus. In another preferredembodiment, the system comprises a wireless remote control fornon-invasively controlling the apparatus. In a preferred embodiment, thesystem comprises a hydraulic operation device for operating theapparatus. In another embodiment, the system comprises comprising amotor or a pump for operating the apparatus. Other components of thesystem are described in more detail in the detailed part of the presentdescription.

Female Sexual Dysfunction (I)

Another object of the present invention to obviate at least some of thedisadvantages in the prior art and provide a new dimension to treatfemale sexual dysfunction positively affecting sexual stimuli andorgasm.

In accordance with this object there is provided a female sexualdysfunction treatment apparatus, comprising a stimulation deviceconfigured to stimulate a female patient's erectile blood flowpassageway to increase the amount of blood in the female erectile tissueand thereby obtaining engorgement with blood of the female erectiletissue by affecting the erectile blood flow passageway.

One advantage of the present invention is that the likelihood to getorgasm will increase by the stimulation device. Another advantage of thepresent invention is that the sexual response to sexual stimuli willincrease.

There is also provided a system comprising an apparatus according to theinvention, and an operation method using an apparatus according to theinvention.

The operation method comprises the steps of: a) creating an opening inthe skin or vaginal wall of the female patient b) dissecting at leastone area of the female erectile tissue, and c) placing the stimulationdevice within said area, adapted to postoperatively stimulate saidfemale erectile tissue on patient command

Further aspects and embodiments are defined in the appended claims,which are specifically incorporated herein by reference.

Definitions

The term “female erectile tissue” refers to both 1) tissue of the femalesexual organs that before or during sexual intercourse are filled withblood including, but not limited to, the corpora cavernosa and thevestibular bulbs, 2) extensions of said tissue, including but notlimited to erectile blood flow passageways including both arterial orvenous blood vessels, and in relevant cases only, and 3) the surroundingtissues including relevant muscle tissue to affect the blood flowpassage way described above, including affecting and increasing thearterial blood flow reaching said female erectile tissue.

The term “free flow” as used throughout the description and the termsdenotes a fluid passageway unaffected by any artificial stimulations inany direction, such as valves or return valves.

The term “tissue” as used throughout the description and the claimsdenotes a cellular organizational level intermediate between cells and acomplete organism. Hence, a tissue is an ensemble of cells, notnecessarily identical, but from the same origin, that together carry outa specific function. For example tissue includes bone.

In general terms the present invention relates an apparatus and methodsof treating a sexual dysfunctional female patient which comprises astimulation device for stimulating the erectile tissues of a femalepatient. In accordance with the invention stimulation can be performedby stimulating so as to affect blood passageways to or from the erectiletissues. The present invention also relates to the accomplishment ofstimulation directly on the corpus cavernosa and thereby affectsstimulation of glands assisting with their secretion of fluidsassociated with natural engorgement. These mentioned routes ofstimulation can either be performed separately or in combination withany apparatus of the invention.

In a first aspect there is provided an apparatus for treating a sexualdysfunctional female patient, comprising a stimulation device adapted tostimulate an erectile blood flow passageway to increase the amount ofblood in the female erectile tissue and thereby obtaining engorgementwith blood of the female erectile tissue by affecting said erectileblood flow passageway.

In one embodiment there is provided an apparatus comprising astimulation device that is able to restrict the blood flow passagewayleaving the female erectile tissue.

In one embodiment there is provided an apparatus, wherein saidstimulation device engages at least one venous blood vessel leading fromsaid female erectile tissue or corpus cavernosum or vestibular bulbs ora muscle affecting such blood flow that drains the female erectiletissue and is adapted to temporarily and at least partially restrict thecross-sectional area of such erectile blood flow passageway that drainsthe female erectile tissue.

In one embodiment there is provided an apparatus, comprising two or morestimulation devices post-operatively and non-invasively adjustable.

In one embodiment there is provided an apparatus, further comprising animplantable control unit for adjusting the stimulation device totemporarily contract the female erectile tissue to restrict the bloodflow leaving the female erectile tissue.

In one embodiment there is provided an apparatus, comprising a controldevice comprising an implanted control unit adapted to control andadjust electrical parameters of said stimulation device, wherein saidcontrol unit is programmable from outside the female patient's body.

In one embodiment there is provided an apparatus, wherein thestimulation device comprising at least one electrical electrode tostimulate the female erectile tissue to achieve engorgement of saidfemale erectile tissue.

In one embodiment there is provided an apparatus, further comprising analarm adapted to generate an alarm signal in response to the lapse of apredetermined time period during which the stimulation device has beenoperating.

In one embodiment there is provided an apparatus, wherein thestimulation device comprises at least one elongated stimulation memberadapted to form the stimulation member into at least a substantiallyclosed loop around a portion of the female erectile tissue, the loopdefining a stimulation opening.

In one embodiment there is provided an apparatus, wherein thestimulation device comprises at least two stimulation device electrodes.

In one embodiment there is provided an apparatus, wherein thestimulation device adapted to increase the arterial blood flow reachingthe female erectile tissue causing engorgement with blood of the femaleerectile tissue.

In one embodiment there is provided an apparatus, wherein the flow ofblood is increased by enlarging the cross-sectional area of the bloodflow passageway, comprising said at least one artery.

In one embodiment there is provided an apparatus, wherein saidstimulation device, comprising a heating member causing engorgement withblood of the female erectile tissue.

In one embodiment there is provided an apparatus, wherein saidstimulation device stimulates a muscle related to said blood flowreaching the female erectile tissue.

In one embodiment there is provided an apparatus, wherein saidstimulation device is adapted to stimulate said muscle, to causerelaxation of said muscle to increase said arterial blood flow.

In one embodiment there is provided an apparatus, wherein saidstimulation device is adapted to stimulate said muscle excessively torelax said muscle.

In one embodiment there is provided an apparatus, wherein saidstimulation device stimulates a muscle related to said blood flowleaving the female erectile tissue.

In one embodiment there is provided an apparatus, wherein saidstimulation device is adapted to stimulate said muscle, to causecontraction of said muscle to restrict said erectile blood flowpassageway.

In a third aspect there is provided an operation method using anapparatus as described above, comprising the steps of:

creating an opening in the skin or vaginal wall of the female patient

dissecting at least one area of the female erectile tissue

placing the stimulation device within said area, adapted topostoperatively stimulate said female erectile tissue on patient command

In one embodiment there is provided an operation method, controllingsaid stimulation device post-operatively and non-invasively from outsidethe body.

In one embodiment there is provided an operation method, placing a powersource within the body.

In one embodiment there is provided an operation method, wherein thestep of placing a stimulation device comprising placing an integratedunit comprising the stimulation device and a power source in the sameintegrated unit.

In one embodiment there is provided an operation method, wherein thestep of placing a power source comprising the step of; placing a controlunit and a rechargeable battery remote from the stimulation device.

In one embodiment there is provided an operation method, wherein thestep of placing a stimulation device comprising placing electricalelectrodes and an electrical wire connected to a power source.

In one embodiment there is provided an operation method, wherein thestep of creating an opening in the skin or vaginal wall of the femalepatient comprising,

inserting a tube or needle into the patients body,

filling the body through the tube or needle with a gas and therebyexpanding a cavity within the female patients body,

inserting at least two laparoscopic trocars into said cavity,

inserting at least one camera trough at least one laparoscopic trocar,and

inserting at least one dissecting tool through at least one laparoscopictrocar.

Female Sexual Dysfunction (III)

Another object of the present invention to obviate at least some of thedisadvantages in the prior art and provide a new dimension to treatfemale sexual dysfunction positively affecting sexual stimuli andorgasm.

In accordance with this object there is provided a female sexualdysfunction treatment apparatus, comprising a device configured toincrease the amount of blood in the female erectile tissue and therebyobtaining engorgement with blood of the female erectile tissue.

One advantage is that the likelihood to get orgasm will increase by thestimulation device. Another advantage is that the sexual response tosexual stimuli will increase.

The implantable device preferably comprises an adjustable restrictiondevice configured to restrict the venous blood flow leaving the femaleerectile tissue, wherein the restriction device is configured

-   -   to constrict at least one venous blood vessel, which drains the        female erectile tissue, to temporarily and at least partially        restrict the venous blood flow leaving the female erectile        tissue, or    -   to constrict the female erectile tissue to temporarily and at        least partially restrict the venous blood flow leaving the        female erectile tissue.

At least one operation device configured to operate said at least onerestriction device may be provided. The operation device may be anintegrated part of the restriction device or the restriction andoperation device may be the same and one unit. The at least oneoperation device may be also implanted at a distance from the at leastone restriction device.

The apparatus preferable include a restriction device that engages atleast one venous blood vessel or corpus cavernosum or vestibular bulbsthat drains the female erectile tissue and is adapted to temporarily andat least partially restrict the cross-sectional area of a blood flowpassageway that drains the female erectile tissue of blood. Preferabletwo or more restriction devices are post-operatively non-invasivelyadjustable.

The adjustment device may comprise;

a hydraulic device,

which may further comprise a reservoir implantable in the patientcontaining hydraulic fluid, wherein an operation device is adapted tooperate the adjustment device by using the hydraulic fluid of thereservoir.

a mechanical device, adapted to squeeze said female erectile tissuemechanically from two or more sides including squeezing between theelement and other human tissue.

The restriction device may comprise at least two elements to be placedon different sides of the female erectile tissue, and the adjustmentdevice is adapted to squeeze the female erectile tissue between theelements to restrict the blood flow leaving the female erectile tissue,and to release the female erectile tissue from the elements to increasethe blood flow leaving the female erectile tissue.

Alternatively the restriction device is adapted to bend a portion of thefemale erectile tissue.

In another hydraulic embodiment the apparatus comprise a conduit placedbetween a reservoir and a cavity placed within said restriction device,including a chamber within said reservoir, wherein the operation deviceis adapted to change the size of the chamber. The reservoir comprisesfirst and second wall portions of the reservoir and wherein saidoperation device is adapted to provide relative displacement between thefirst and second wall portions of the reservoir, in order to change thevolume of said chamber, wherein said fluid is permitted free flow allthe way from the reservoir via the conduit to the cavity or the oppositedirection thereof.

The restriction device may comprise at least one elongated restrictionmember adapted to form the restriction member into at least asubstantially closed loop around a portion of the female erectiletissue, the loop defining a restriction opening, whereby the adjustmentdevice is adapted to adjust the restriction member in the loop to changethe size of the restriction opening.

In an alternative embodiment the apparatus may comprise a stimulationdevice adapted to increase the arterial blood flow reaching the femaleerectile tissue causing engorgement with blood of the female erectiletissue.

The stimulation device may comprise a heating member causing engorgementwith blood of the female erectile tissue.

The apparatus may further comprise a control device for manuallycontrolling the at least one restriction device from outside thepatients body, and may further comprise a control device for controllingthe level of restriction.

Alternatively the apparatus may comprise a control device and at leastone sensor adapted to detect a physical parameter of the patient and/ora functional parameter of the apparatus, wherein said control devicecomprises a control unit adapted to automatically control the at leastone restriction device based on input from said at least one sensor.

The apparatus preferable comprises an implantable adjustment device foradjusting the restriction device to temporarily contract the femaleerectile tissue to restrict the blood flow leaving the female erectiletissue and an implantable operation device for operating the adjustmentdevice. The operation device and adjustment device may be the same ordifferent devices.

The operation device may comprise many different embodiments such as;

an electromagnetic device, wherein the restriction is achieved by saidelectromagnetic device

an electric motor, wherein the restriction is achieved by said electricmotor

a hydraulic device, wherein the restriction is achieved by saidhydraulic device

a mechanical device, wherein the restriction is achieved by saidmechanical device

a motor, wherein the restriction is achieved by said motor, wherein themotor may comprise a servo

a pump operating a hydraulic device.

In a preferred embodiment, the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe apparatus

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the apparatus.

In a preferred embodiment, the system comprises a hydraulic operationdevice for operating the apparatus.

In one embodiment, the system comprises comprising a motor or a pump foroperating the apparatus.

There are also included a method for operating and using saidrestriction device. In a first aspect there is provided an operationmethod using the apparatus comprising the steps of:

creating an opening in the skin or vaginal wall of the female patient

dissecting an one area of the female erectile tissue

placing the restriction device within said area, adapted topostoperatively restrict said female erectile tissue on patient command

Further step may include; placing an operation device and a power sourcewithin the body.

The step of placing a restriction device may comprise placing anintegrated unit comprising the restriction device and an operationdevice in the same integrated unit.

The step of placing a power source may comprise; placing a control unitand a rechargeable battery remote from said restriction device.

The operation method preferable includes controlling said restrictiondevice post-operatively and non-invasively from outside the body.

In a second aspect there is provided an laparoscopic operation method,wherein the step of creating an opening in the skin or vaginal wall ofthe female patient comprising:

inserting a tube or needle into the patients body,

filling the tube or needle with a gas and thereby expanding a cavitywithin the female patients body,

inserting at least two laparoscopic trocars into said cavity,

inserting at least one camera trough at least one laparoscopic trocar,

inserting at least one dissecting tool through at least one laparoscopictrocar.

In a third aspect there is provided an operation method using anapparatus or a system as described above. The operation method comprisescreating an opening in the skin or vaginal wall of the female patient,dissecting one area of the female erectile tissue and placing therestriction device within said area, adapted to postoperatively restrictsaid female erectile tissue on patient command

In one embodiment there is provided an operation method where saidrestriction device is post-operatively and non-invasively controlledfrom outside the body.

In one embodiment there is provided an operation method where anoperation device and a power source is placed within the body.

In one embodiment there is provided an operation method wherein the stepof placing a restriction device comprises placing an integrated unitcomprising the restriction device and an operation device in the sameintegrated unit.

In one embodiment there is provided an operation method, wherein thestep of placing a power source comprises the step of; placing a controlunit and a rechargeable battery remote from the restriction device.

In one embodiment there is provided a operation method, wherein the stepof creating an opening in the skin or vaginal wall of the female patientcomprises,

inserting a tube or needle into the patients body,

filling the body through the tube or needle with a gas and therebyexpanding a cavity within the female patients body,

inserting at least two laparoscopic trocars into said cavity,

inserting at least one camera trough at least one laparoscopic trocar,

inserting at least one dissecting tool through at least one laparoscopictrocar

Definitions

The term “female erectile tissue” refers to 1) tissue of the femalesexual organs that before or during sexual intercourse are filled withblood including, but not limited to, the corpora cavernosa of theclitoris and the vestibular bulbs. 2) extensions of said tissue,including but not limited to blood vessels and the surrounding tissues.

The term “free flow” refers to a fluid passageway without anyrestrictions in any direction, such as valves or return valves.

The term “tissue” refers to all human tissue, including bone.

Intestinal disorders

“Artificial reservoir”

Another object of the present invention is to provide an improved systemand method for treating a patient having a disorder related to thepatient's intestine.

Internal Reservoir with Implantable Flow Control Device

A system according to the invention for treating a patient having adisorder related to the patient's intestine comprises an artificial orartificially modified reservoir adapted for receiving and temporarilycollecting therein intestinal contents. The reservoir is further adaptedto remain within the patient's body when emptying the reservoir. Thesystem further comprises an at least partly artificial flow controldevice implantable in the patient's body and adapted to control flow ofthe intestinal contents from the reservoir.

The Internal reservoir will substantially extend the time period beforethe patient feels a need to excrete feces. Rather than using an externalbag for that purpose which has to be attached, removed and cleaned, theinternal reservoir remains within the patient's body. By combining suchinternal reservoir with an appropriate flow control device for emptyingthe reservoir, the patient's living circumstances are substantiallyimproved.

Reservoir Formed from Intestine or Human Tissue

According to a first general embodiment, the reservoir may be formedfrom at least one bent portion of the patient's intestine. Morespecifically, laterally adjacent sections of the intestine are cut openalong their mutual contact line and the resulting upper halves and lowerhalves thereof are then interconnected so as to form the reservoir. Theinterconnection can advantageously be made with staplers, possiblyincluding bonding with a biocompatible glue, but sewing is likewise anoption. Alternatively, the reservoir may also be formed from surgicallymodified and connected human tissue.

Isolated Lateral Arrangement of Reservoir

The reservoir may be laterally connected to the intestine by means of asingle passage through which the intestinal contents are fed in bothways, i.e. from the intestine into the reservoir and, when the reservoiris emptied, in the reverse direction from the reservoir back to theintestine and further out of the body. Accordingly, the system accordingto the invention comprises a passage in flow communication with thereservoir and adapted to being connected to a surgically created lateralopening in a wall of the patient's intestine, said passage beingarranged for transferring intestinal contents to and from the reservoir.

Through-Flow Arrangement of Reservoir

Instead of a single passage, two passage may be provided, a firstpassage leading feces to the reservoir and a second passage differentfrom the first passage leading the feces from the reservoir when thereservoir is emptied.

Accordingly the system of the present invention may comprise a firstpassage in flow communication with the reservoir and adapted to beingconnected to a surgically created first opening of the patient'sintestine, said first passage being arranged for transferring intestinalcontents to the reservoir, and further comprising a second passage inflow communication with the reservoir, said second passage beingarranged for transferring intestinal contents from the reservoir.

The second passage must not necessarily redirect the feces back to theintestine, it may as well be adapted to being surgically connected to asurgically created stoma or to the patient's rectum or anus or to tissueadjacent the patient's anus.

On the other hand, rather than directly connecting the second passage tothe stoma or anus, the second open end portion may be adapted to beingconnected to a healthy portion of the patient's small intestine or ofthe patient's large intestine. Since the small intestine and largeintestine have different diameters and wall thickness, the structure ofthe second open end portion can be substantially different in thesecases. The healthy portion of the intestine may then be connected to thepatient's rectum or anus or to tissue adjacent the patient's anus or touse that portion for creating a stomy.

Lateral Attachment

In particular, the second passage may be adapted to being surgicallyconnected to a second surgically created opening of the patient'sIntestine, this not being restricted to a connection to across-sectional opening. More specifically, according to a preferredembodiment, the second passage is adapted to being connected to alateral opening in the wall of the patient's intestine. Similarly, it ispreferred that also the first passage is adapted to being connected to alateral opening in the wall of the patient's intestine. Lateralattachment of the passage or passages between the intestine and thereservoir has the advantage that the forces resulting from theperistaltic waves moving along the intestine have less impact on theconnection. In frontal connections, i.e. where the reservoir is attachedto a cross-sectional opening of the intestine, the peristaltic wavestend to pull the intestine away from the connection, this requiringspecial securing measures.

In order to connect the reservoir to the intestine, the first passage ispreferably adapted to being bonded and/or sewn and or stapled to theintestine, this applying to both a cross-sectional and a lateralattachment.

Valve as Part of the Flow Control Device

As a main element of the flow control device for controlling flow fromthe reservoir, in particular for emptying the reservoir, there may beprovided one or more valve and/or pump.

Exit Valve

For instance, the at least one valve may include an exit valvepreventing intestinal contents flow from the reservoir in its closedposition. Preferably, the exit valve is a normally closed valve so thatno energy is needed to keep the valve closed during the system'sinactive periods.

Entry Valve in Addition to Exit Valve

In addition, the flow control device may comprise an entry valveallowing intestinal contents to flow towards the reservoir in its openposition. This can be advantageous particularly during the emptying ofthe reservoir, when the entry valve should be closed. Therefore, theentry valve is preferably a normally open valve. Accordingly, the exitvalve and the entry valve are preferably adapted to cooperate such thatwhen one of the two valves is closed, the respective other valve isopen, and vice versa.

Valve Arrangement (Internal, Intersecting, Outside)

The valves can be arranged in many different ways, depending on the typeof valve. For instance, at least one of the valve or valves,respectively, can be adapted to being permanently implanted inside thepatient's intestine. Or, where at least one of the valve or valves,respectively, has an upstream open end and has a downstream open end influid connection with the upstream open end, the upstream open end canbe adapted to being connected to a surgically created opening of thepatient's intestine and the downstream open end can be adapted to beingconnected to either one of a surgically created opening of the patient'sintestine, a surgically created stoma, the patient's anus or tissueadjacent the patient's anus. Alternatively, at least one of the valve orvalves, respectively, may be adapted to being implanted inside thepatient's body outside a section of the patient's intestine and maycomprise at least one element adapted to act on the intestine sectionfrom the outside thereof so as to act on and, in particular, preventintestinal contents flow through the intestine section. This lattervalve arrangement is advantageous inasmuch its installment does notrequire any surgery on the respective part of the intestine.

Valve Types

As regards the various valve types that may be employed, the at leastone valve may e.g. comprise a central opening which is normally closedby resilient means that can be urged apart mechanically by inserting aconduit through the central opening so as to open the central opening ofthe valve. In the simplest embodiment, the valve may be opened bymechanical force, such as by inserting a tube from outside the patient'sbody through the valve. The valve in this case can be a simplenon-return valve.

According to a more complex embodiment, the at least one valve maycomprise a compartment with a variable volume adapted to open and closethe valve by changing the compartment's volume. Advantageously, the atleast one valve comprises at least one passage for filling and emptyingthe compartment with hydraulic fluid. The compartment preferably has atleast one flexible wall defining an opening for the intestine or aconduit of the reservoir to pass through, the opening being adapted toclose upon increase of the compartment's volume.

According to a different embodiment, the at least one valve may be aflap valve permanently implanted inside the patient's intestine. Theflap valve may for instance comprise a rotatable disc.

According to a very specific embodiment, where the at least one valve isimplanted inside the patient's body outside a section of the patient'sintestine to act on the intestine section from the outside thereof, thevalve may comprise at least one electrical stimulation device adapted toelectrically stimulate muscle or neural tissue of an intestine sectionso as to cause at least partial contraction of the intestine section.This is a very gender way of constricting the intestine. The stimulationdevice preferably comprises at least one electrode adapted to applyelectric pulses to the intestine section.

It is particularly advantageous to make use of a stimulation devicewhich is adapted to stimulate different portions of the intestinesection over time. Thus, different portions of the intestine section canbe constricted by stimulation at different times in any predeterminedstimulation pattern, thereby giving the intestine portions currently notstimulated time to recover and, thus, improving the blood circulation inthe respective intestine section.

Furthermore, the stimulation device can specifically be adapted tostimulate, over time, the different portions of the intestine section ina wave like manner in a direction opposite to natural intestinalcontents flow. As a result, the valve counteracts the natural intestinalcontents flow, thereby improving the valve's closing function.

Alternatively, or preferably in addition to the stimulation device, theat least one valve may comprise a constriction device implanted in thepatient's body for at least partly constricting the intestine sectionmechanically from outside the intestine section. Where the stimulationdevice is combined with the constriction device, the stimulation deviceand the constriction device preferably act on the same intestinesection. In that case, it is advantageous if the constriction device inits normal condition constricts the intestine section only partly, inorder not to damage the intestine over time. Complete constriction and,thus, closing of the intestine may then be obtained by additionallystimulating the intestine section in a manner as described before.

In addition, when constriction of the intestine section caused by theconstriction device is released, the stimulation device may, ifaccordingly adapted, be used to pump intestinal contents along theintestine section by, over time, stimulating different portions of theintestine section in a wave like manner in a direction of naturalintestinal contents flow. In this situation, the valve may incorporatethe additional function of a pump for actively supporting the dischargeof feces from the human body.

Pump as Part of the Implantable Flow Control Device

Where the flow control device comprises a pump for emptying thereservoir, a variety of different types of pumps may be employed.

For instance, the pump may be adapted for emptying the reservoir bysqueezing the reservoir, if the reservoir has a flexible wall thatallows for squeezing.

In particular, the pump and the reservoir can be separate from eachother and the pump can be adapted to being implanted in the patient'sbody separate from but in close proximity to the reservoir so as to acton the reservoir from the outside thereof. For instance, the reservoirmay have a flexible wall and the pump may comprise a movable piston,with a front end of the piston adapted to act on the flexible wall ofthe reservoir from the outside thereof upon advancement of the piston.

Alternatively, the pump and the reservoir can be fixedly connected toone another. For instance, the reservoir may be formed by a bellow, saidbellow having an end wall closing the bellow at one end thereof and saidend wall making part of the pump such that a volume of the bellow isreduced upon advancement of said end wall. Preferably, the bellow ismade of a resilient material so as to urge the bellow into a normallyexpanded position.

In another embodiment where the pump and the reservoir are fixedlyconnected to one another, the pump comprises a movable piston with afront end of the piston extending into the reservoir such that a volumeof the reservoir can be reduced upon advancement of the piston.Preferably, the pump and the reservoir are comprised in a common housingso that they can be implanted as a unit.

Furthermore, it is advantageous if the piston is spring loaded so as tourge the piston into a normally retracted position.

As a further alternative, the pump may be adapted for being permanentlyarranged inside the reservoir.

As a still further alternative, the pump and the reservoir can beprovided separate from each other with the pump being implanted insidethe patient's body outside the patient's intestine. Similarly to thevery specific valve embodiment described above, according to thisalternative the pump comprises at least one electrical stimulationdevice adapted to electrically stimulate muscle or neural tissue of anintestine section so as to cause at least partial contraction of theintestine section. Again, the stimulation device preferably comprises atleast one electrode adapted to apply electric pulses to the intestinesection. Furthermore, the stimulation device may be adapted to stimulatedifferent portions of the intestine section over time so as to pumpintestinal contents along the intestine section by, over time,stimulating the different portions of the intestine section in a wavelike manner in the direction of natural intestinal contents flow.

Also, the pump may comprise a constriction device similar to the valveembodiment described earlier for at least partly constricting theintestine section mechanically, whereby the constriction device ispreferably adapted to pump intestinal contents along the intestinesection by, over time, constricting different portions of an intestinesection in a wave like manner in the direction of natural intestinalcontents flow.

Again, the stimulation device may be combined with the constrictiondevice so as to pump the intestinal contents along the intestine sectionby, over time, stimulating the different portions of the intestinesection in a wave like manner in a direction of natural intestinalcontents flow, when constriction of the intestine section caused by theconstriction device is released at the respective portions.

Finally, the pump may also be constituted by a manually drivable pumpand may comprise an actuator for manually driving the pump. The actuatorin this case is preferably arranged for subcutaneous implantation so asto be operable from outside the patient's body.

Motor

Where the valves or pump or any other element of the flow control deviceis not or not only manually drivable, at least one motor can be providedfor automatically driving one or more of the elements of the flowcontrol device. The motor is preferably arranged to be driven byelectric or electromagnetic energy.

A motor in the sense of the present invention is a device thattransforms energy other than mechanical energy into mechanical energy.While a pump in the sense of the present invention is a device foradvancing liquid or pasty material, a pump may at the same time be amotor in certain circumstances, such as where the transformation ofenergy into mechanical energy causes advancement of the liquid or pastymaterial without any intervening mechanical means such as a piston,bellow or the like.

For instance, the at least one motor can be arranged for driving atleast one of the valve or valves, respectively, between its closed andopen position. Also, the at least one motor can be arranged for drivingthe pump.

A manually operable switch may be provided for activating the at leastone motor, the switch being preferably arranged for subcutaneousimplantation so as to be operable from outside the patient's body.

Energy Source

In a preferred embodiment, an energy source is provided for supplyingenergy directly or indirectly to at least one energy consuming part ofthe system. Preferably, the energy source includes a battery or anaccumulator, such as one or more of a rechargeable battery and acapacitor, as an energy storage means. The energy storage means isadvantageously adapted for being implanted inside the patient's body.

Wireless Energy Transmission

Energy is preferably transmitted wirelessly. Thus, where the energysource is provided for supplying energy directly or indirectly to atleast one energy consuming part of the system, the energy source maycomprise a wireless energy transmitter adapted to wirelessly transmitenergy from outside the patient's body to the at least one energyconsuming part. Alternatively, where the energy source includes abattery or an accumulator, in particular one which is implanted in thepatient's body, the energy source may comprise a wireless energytransmitter adapted to wirelessly transmit energy from outside thepatient's body to the energy storage means.

Energy Transmission Feedback

A feedback subsystem, which can make part of a control device describedsubsequently, can advantageously be provided to wirelessly send feedbackinformation related to the energy to be stored in the accumulator frominside the human body to the outside thereof. The feedback informationis then used for adjusting the amount of wireless energy transmitted bythe energy transmitter. Such feedback information may relate to anenergy balance which is defined as the balance between an amount ofwireless energy received inside the human body and an amount of energyconsumed by the at least one energy consuming part. Alternatively, thefeedback information may relate to an energy balance which is defined asthe balance between a rate of wireless energy received inside the humanbody and a rate of energy consumed by the at least one energy consumingpart.

Also, the transmission of energy from the energy storage means to the atleast one energy consuming part may be performed wirelessly by means ofan accordingly adapted wireless energy transmitter.

Preferably, in order to reduce the number of parts and possibly increasethe system's efficiency, the energy consuming part can be adapted todirectly transform the wirelessly transmitted energy into kineticenergy. Otherwise, it will be necessary to provide an implantable energytransforming device for transforming the wireless energy, preferablyinto electric energy. In this case, it is further preferred to set upthe system such that the energy consuming part is driven with theelectric energy, as said energy transforming device transforms thewireless energy into the electric energy.

The energy transmitter can be adapted to generate an electromagneticfield, a magnetic field or an electrical field. The wireless energy maybe transmitted by the energy transmission device by at least onewireless signal. More specifically, the energy transmitter may beadapted to transmit the energy by at least one wireless energy signal,which may comprise an electromagnetic wave signal, including at leastone of an infrared light signal, a visible light signal, an ultra violetlight signal, a laser signal, a microwave signal, an X-ray radiationsignal, and a gamma radiation signal. Also, the wireless energy signalmay comprise a sound or ultrasound wave signal. Furthermore, thewireless energy signal may comprise a digital or analog signal or acombination thereof.

Galvanic Energy Transmission

Where energy is not transmitted wirelessly, galvanic coupling elementsshould be provided at least between the energy source and the motor fortransmitting energy to the motor in contacting fashion.

Control Unit

It is advantageous to provide a control unit adapted to directly orindirectly control one or more elements of the system, such as forcontrolling opening of the exit valve and/or closing of the entry valve,in particular in a manner such that when one of the two valves isclosed, the respective other valve is open, and vice versa. The controlunit can also be adapted to control actuation of the pump.

The control unit is preferably operable by the patient, e.g.particularly in order to empty the reservoir.

At least part of the control unit may be adapted to be implantable inthe patient's body. For instance, a manually operable switch may beprovided for activating the control unit, the switch preferably beingarranged for subcutaneous implantation so as to be operable from outsidethe patient's body. Also, the control unit may comprise a first partadapted for implantation in the patient's body and a second part adaptedto cooperate with the first part from outside the patient's body. Inthis case, the control unit can be adapted to transmit data from theexternal second part of the control unit to the Implanted first part ofthe control unit in the same manner as energy is transmitted to the atleast one energy consuming part.

That is, the second part of the control unit may be adapted towirelessly transmit a control signal to the implantable first part ofthe control unit for controlling the at least one energy consuming partfrom outside the patient's body. Also, the implantable first part of thecontrol unit may be programmable via the second part of the controlunit. Furthermore, the implantable first part of the control unit may beadapted to transmit a feedback signal to the second part of the controlunit

Sensor

Furthermore, a physical parameter sensor adapted to directly orindirectly sense a physical parameter of the patient can be provided.The physical parameter sensor may be adapted to sense at least one ofthe following physical parameters of the patient: a pressure within thereservoir, a pressure within the patient's intestine, an expansion ofthe reservoir, a distension of an intestinal wall of the patient'sintestine, a movement of the intestinal wall.

Similarly, a functional parameter sensor adapted to directly orindirectly sense a functional parameter of the system can be provided,wherein the functional parameter sensor may be adapted to sense at leastone of the following functional parameters of the system: a pressureagainst a part of the system such as the reservoir, a distension of apart of the system such as a wall of the reservoir, an electricalparameter such as voltage, current or energy balance, a position ormovement of a movable part of the system.

Preferably, an indicator is coupled to the sensor or sensors, theindicator being adapted to provide a signal when a sensor senses a valuefor the parameter beyond a predetermined threshold value. The sensorsignal may comprise at least one of the following types of signals: asound signal, a visual signal.

Intestinal Contents Collecting Device (with “External” Pump)

As mentioned before, in the simplest embodiment, an intestinal contentscollecting device may used to be temporarily applied from outside thepatient's body when the reservoir is to be emptied. According to apreferred embodiment, the collecting device may comprise a front openend adapted to be applied towards the exit valve so as to provide a flowpassage from the exit valve towards the collecting device. Morespecifically, the collecting device front open end is preferably adaptedto be applied to the exit valve so as to open the valve and therebyprovide said flow passage towards the collecting device. Where the exitvalve is normally closed by resilient means, said front open end isadapted to be inserted through the central opening of the exit valve soas to urge apart the resilient means normally closing the centralopening.

The collecting device preferably comprises a suction pump, which maycomprise a piston-cylinder-arrangement. The suction pump may be adaptedto be driven manually, in particular where it is intended for use as aback-up pump for a situation where the pump of the flow control deviceis out of operation. However, preferably a motor is connected to thesuction pump for driving the pump automatically.

Method of Treatment (Implantation)

The invention does not only relate to the system described above, butalso to a method of treating a patient having a disorder related to thepatient's intestine.

Reservoir Formed from Intestine

As mentioned before, the reservoir of the system may be made from thepatient's intestine. A respective surgical method of treating thepatient would comprise the steps of:

cutting the patient's skin and abdominal wall,

dissecting an area of the patient's intestine,

cutting the patient's intestine along a mutual contact line of laterallyadjacent sections of a bent portion thereof and connecting by suturingand/or stapeling the resulting upper and lower halves of the intestineso as to form a reservoir,

implanting a flow control device so as to permanently reside inside thepatient's body and adapted to control flow of intestinal contents fromthe reservoir to outside the patient's body, and

thereafter, permanently closing the abdominal wall and skin.

A respective laparoscopic surgical method of treating the patient wouldcomprise the steps of:

making a small opening in the patients skin and abdominal wall,

introducing a needle in the abdominal cavity,

inflating the abdominal cavity with gas,

inserting at least one trocar into the cavity,

introducing a camera through the trocar, inserting at least onedissecting instrument preferably through a second trocar,

dissecting an area of the intestine,

cutting the patient's intestine along a mutual contact line of laterallyadjacent sections of a bent portion thereof and connecting by suturingand/or stapling the resulting upper and lower halves of the intestine soas to form a reservoir,

implanting a flow control device so as to permanently reside inside thepatient's body and adapted to control flow of intestinal contents fromthe reservoir to outside the patients body,

extracting the instruments, camera and trocar, and in relation thereto

suturing, if necessary, the abdominal wall and permanently closing theskin.

As also mentioned before, the system may be surgically connected to asurgically created stoma or to the patient's rectum or anus or to tissueadjacent the patients anus. This would require, where a stomy isinvolved, the following additional steps:

cutting the patient's skin and abdominal wall so as to create an openingfor an intestinal stomy,

dissecting the area of the opening,

dividing the intestine downstream of the reservoir so as to maintain anupstream natural intestine section still connected to the reservoir witha cross-sectional opening at the downstream end thereof,

dissecting the mesentery of the upstream natural intestine section inthe area of the cross-sectional opening at the downstream end thereof toprepare for creating the intestinal stomy,

advancing the upstream natural intestine section through the abdominalwall and skin and

suturing the upstream natural intestine section in the area of thecross-sectional opening to the skin with the intestinal mucose turnedinside out, thereby achieving the intestinal stomy.

Where the system may be surgically connected to a the patients anus orto tissue adjacent the patient's anus, this would require the followingadditional steps:

dividing the intestine so as to create an upstream natural intestinesection having a cross-sectional opening at the downstream end thereofand a downstream natural intestine section leading to the patient'sanus,

dissecting the area of the patient's anus and surgically separating thedownstream natural intestine section from the patient's anus, whereasthe steps of dividing the intestine and separating the intestine sectionleading to the patient's anus can alternatively be carried out inreversed order,

dissecting the mesentery of the upstream natural intestine section inthe area of the cross-sectional opening at the downstream end thereof toprepare for connecting the upstream natural intestine section to thepatient's anus or tissue adjacent the patient's anus,

advancing the downstream end of the upstream natural intestine sectionthrough the patient's anus, and

suturing the cross-sectional opening of the upstream natural intestinesection to the patient's anus or tissue adjacent the patients anus.

In line with the very specific valve embodiment described previously,the method may further involve the step of implanting at least oneelectrical stimulation device in the vicinity of an intestine section soas to allow for at least partial contraction of the Intestine section bymeans of electrical stimulation of muscle or neural tissue with the aidof the electrical stimulation device. Preferably, electric pulses areapplied to the intestine section by means of the stimulation device.

Preferably the stimulation device is implanted along the intestinesection so as to be able to stimulate different portions of theintestine section over time. More specifically, the stimulation devicemay be implanted to pump intestinal contents along the intestine sectionby, over time, stimulating the different portions of the intestinesection in a wave like manner.

Also, a constriction device may be implanted so as to allow for at leastpartial mechanical constriction of the intestine section by means of theconstriction device. The constriction device may advantageously combinedwith the stimulation device so as to allow for adding furtherconstriction of the intestine section by stimulating the intestinesection with stimulation pulses. In particular, this may be used forpumping intestinal contents along the intestine section by, over time,stimulating the different portions of the intestine section in a wavelike manner, when constriction of the intestine section caused by theconstriction device is released.

Artificial Reservoir

While the reservoir may be made from the patient's intestine in themanner as described earlier, an artificial reservoir made fromnon-biologic material may as well be used. In this case, a surgicalmethod of treating a patient may comprise the steps of:

cutting the patient's skin and abdominal wall,

dissecting an area of the patient's intestine,

surgically creating an opening in the dissected intestinal area,

affixing to the opening a reservoir so as to receive and temporarilycollect therein intestinal contents from the patient's intestine,

implanting a flow control device so as to permanently reside inside thepatient's body and adapted to control flow of intestinal contents fromthe reservoir to outside the patient's body, and

suturing the abdominal wall and skin.

A respective laparoscopic surgical method of treating a patient maycomprise the steps of:

making a small opening in the patient's skin and abdominal wall,

introducing a needle in the abdominal cavity,

inflating the abdominal cavity with gas,

inserting at least one trocar into the cavity.

introducing a camera through the trocar,

inserting at least one dissecting instrument preferably through a secondtrocar,

dissecting an area of the intestine,

surgically creating an opening in the dissected intestinal area,

affixing to the opening an artificial reservoir so as to receive andtemporarily collect therein intestinal contents from the patient'sintestine and

implanting a flow control device so as to permanently reside inside thepatient's body and be adapted to control flow of intestinal contentsfrom the reservoir to outside the patient's body,

connecting the intestine to the artificial reservoir with securingmeans,

extracting the instruments, camera and trocar, and in relation thereto

suturing, if necessary, the abdominal wall and permanently closing theskin.

In the afore described embodiments the reservoir is attached to anopening of the intestine, which opening may be a lateral opening createdin the intestinal wall so as to allow intestinal content to flow to thereservoir and, possibly, also from the reservoir back to the intestinethrough the same opening. However, the opening may as well be across-sectional opening of the intestine, which can be obtained bydividing the intestine. In the latter case of a connecting the reservoirto a cross-sectional opening of the intestine, a respective surgicalmethod of treating a patient would comprise the steps of:

cutting the patient's skin and abdominal wall,

dissecting an area of the patient's intestine,

dissecting a portion of the dissected intestinal area such thatintestinal mesentery connected thereto is opened in such a way thatsupply of blood through the mesentery to the dissected intestinal areais maintained as much as possible on both sides of the dissectedportion,

dividing the patient's intestine in the dissected portion so as tocreate an upstream part of the intestine with a first intestinal openingand a downstream part of the intestine with a second intestinal openingwith the mesentery still maintaining a tissue connection between theupstream and downstream intestine parts.

affixing to the first intestinal opening an artificial reservoir so asto receive and temporarily collect therein intestinal contents from thepatient's intestine,

affixing the reservoir to the second intestinal opening so as to allowfor discharging intestinal contents from the reservoir through thesecond intestinal opening,

implanting a flow control device so as to permanently reside inside thepatient's body and be adapted to control flow of intestinal contentsfrom the reservoir through the downstream intestine part, and

suturing the abdominal wall and skin.

A corresponding laparascopic surgical method of treating a patientcomprises the steps of:

making a small opening in the patient's skin and abdominal wall,

introducing a needle in the abdominal cavity.

inflating the abdominal cavity with gas,

inserting at least one trocar into the cavity,

introducing a camera through the trocar,

inserting at least one dissecting instrument preferable through at leasta second trocar,

dissecting an area of the intestine,

dissecting a portion of the dissected Intestinal area such thatintestinal mesentery connected thereto is opened in such a way thatsupply of blood through the mesentery to the dissected intestinal areais maintained as much as possible on both sides of the dissectedportion,

dividing the patient's intestine in the dissected portion so as tocreate an upstream part of the intestine with a first intestinal openingand a downstream part of the intestine with a second intestinal openingwith the mesentery still maintaining a tissue connection between theupstream and downstream intestine parts,

affixing to the first intestinal opening an artificial reservoir so asto receive and temporarily collect therein intestinal contents from thepatient's intestine,

affixing the reservoir to the second intestinal opening so as to allowfor discharging intestinal contents from the reservoir through thesecond intestinal opening,

implanting a flow control device so as to permanently reside inside thepatient's body and be adapted to control flow of intestinal contentsfrom the reservoir to the downstream intestine part,

connecting the intestine to the artificial reservoir with securingmeans,

extracting the instruments, camera and trocar, and in relation thereto

suturing, if necessary, the abdominal wall and permanently closing theskin.

Depending on where the intestine is divided, the “second”cross-sectional intestinal opening is created either in the patient'ssmall intestine or in the patient's large intestine.

Where the downstream part of the intestine is to be attached to asurgically created stomy, this may involve the following additionalsteps:

cutting the patient's skin and abdominal wall to create an opening foran intestinal stomy,

dissecting the area of the opening,

dividing the downstream intestine part so as to create at the downstreamend of the downstream intestine part a third opening,

dissecting the mesentery of the downstream intestine part in the area ofthe third opening to prepare for creating the intestinal stomy,

advancing the downstream intestine part through the abdominal wall andskin and

suturing the third opening to the skin with the intestinal mucosa turnedinside out, thereby achieving the intestinal stomy.

Where the downstream part of the intestine is to be attached to thepatients anus or tissue adjacent the patient's anus, rather than to asurgically created stomy, this may involve the following additionalsteps:

dividing the intestine so as to create an upstream natural intestinesection having a cross-sectional opening at the downstream end thereofand a downstream natural intestine section leading to the patient'sanus,

dissecting the area of the patient's anus and surgically separating thedownstream natural intestine section from the patient's anus, whereasthe steps of dividing the intestine and separating the intestine sectionleading to the patient's anus can alternatively be carried out inreversed order,

dissecting the mesentery of the upstream natural intestine section inthe area of the cross-sectional opening at the downstream end thereof toprepare for connecting the upstream natural intestine section to thepatient's anus or tissue adjacent the patient's anus,

advancing the downstream end of the upstream natural intestine sectionthrough the patient's anus, and

suturing the cross-sectional opening of the upstream natural intestinesection to the patient's anus or tissue adjacent the patient's anus.

Exit Valve

Where the flow control device comprises an exit valve preventingintestinal contents to flow through the valve in its closed position,the step of implanting the flow control device may comprise:

cutting at least one portion of the patient's intestine so as to createat least one artificial opening in the intestine downstream of thereservoir,

affixing the exit valve to the artificial intestinal opening, and

connecting the exit valve to a pre-existing opening in the patient'sbody.

The step of connecting the exit valve to a pre-existing opening in thepatient's body may comprise either one of affixing the exit valve to thepatient's anus or tissue adjacent the patient's anus, to a portion ofthe patient's intestine leading to the patient's anus, or—aftersurgically creating an artificial stoma in the patient's abdominal walland skin—to the surgically created stoma. Alternatively, the exit valvemay be connected to a portion of the patient's intestine and thatportion of the patient's intestine may be used to create the stomy.

Lateral Connection (of Reservoir, Pump or Valve) to Intestine

It was described before how the reservoir may be attached between twocross-sectional openings of a divided intestine. It is, however, alsopossible to surgically create an opening in the dissected intestinalarea by cutting the artificial intestinal opening into a lateral wall ofthe intestine so as to create a lateral artificial intestinal opening,and attach the reservoir to the lateral opening. In this case, theintestine is preferably permanently closed downstream of the lateralartificial intestinal opening.

By-Pass Connection

Where two lateral artificial intestinal openings are cut at differentlocations of the intestine's lateral wall, the intestine may further becut between the two locations and the cut ends permanently closed or theintestine may simply be permanently closed between the two locations,e.g. by suturing and/or stapling, wherein the reservoir is affixed inflow connection intermediate the two artificial intestinal openings.

End-Connection (of Reservoir or Exit Valve; Sleeve/Bulge Connector)

Where the step of surgically creating an opening in the dissectedintestinal area comprises cutting the artificial intestine completely ina crosswise direction so as to create at least one artificial opening inthe intestine, the step of affixing to the opening may comprise:

connecting a conduit to a section of the intestine by inserting an endof the conduit into the artificial intestinal opening, and

placing a flexible sleeve so as to extend over the intestine and conduitsuch that at least part of the intestine is located intermediate thesleeve and the outer surface of the conduit.

Where the flexible sleeve is mounted on the outer surface of the conduitso as to be foldable upon itself, the step of placing the flexiblesleeve so as to extend over the intestine and conduit may comprisefolding the flexible sleeve upon itself such that at least part of theintestine is located intermediate the folded sleeve.

Alternatively, or in addition, where the step of surgically creating anopening in the dissected intestinal area comprises cutting theartificial intestine completely in a crosswise direction so as to createat least one artificial opening in the intestine, the step of affixingto the opening may comprise:

connecting a conduit having a bulge formed on the outside thereof to asection of the intestine by inserting an end of the conduit into theartificial intestinal opening so that the intestine extends over thebulge from one side of the bulge, and

advancing a blocking ring over the intestine towards the bulge from therespective other side of the bulge such that the intestine is locatedintermediate the conduit's outer surface and the blocking ring.

The afore-mentioned conduits with a sleeve or with a bulge serve toimprove the strength of the connection against forces which result fromthe peristaltic movement of the intestine and tend to pull on theintestine. The conduit may also combine a sleeve and a bulge. Theconduit may lead to or from the reservoir or may make part of the valveor pump.

External/Internal Arrangement of Exit Valve

Where the flow control device comprises an exit valve preventingintestinal contents flow through the valve in its closed position, thestep of implanting the flow control device may comprise either placingthe exit valve outside and adjacent to a section of the intestinedownstream of the reservoir so as to allow acting on said intestinesection from the outside thereof by means of the exit valve, or affixingthe exit valve within a section of the intestine downstream of thereservoir so as to allow closing said intestine section by means of theexit valve when the valve is in its closed position.

Bond and Suture Connection

The step of affixing to the opening preferably comprises bonding,possibly further including suturing and/or stapling, an element to theintestine so as to surround and close the artificial intestinal opening.

Pump

Where the flow control device comprises a pump for emptying thereservoir, the step of implanting the flow control device may compriseimplanting the pump in the patient's abdomen either separate from but inclose proximity to the reservoir so that it can act on the reservoirfrom the outside thereof, or fixedly connected to the reservoir.Alternatively, the pump may be implanted in the reservoir so that it canact on the intestinal contents in the reservoir from the inside thereservoir.

Manual Drive

Where the flow control device comprises an actuator for manually drivingthe pump, such actuator is preferably implanted subcutaneously so as tobe operable from outside the patient's body.

Motor/Pump

As mentioned before, at least one motor and/or a pump may be implantedfor automatically driving one or more elements of the flow controldevice.

Switch

Where the motor and/or pump comprises a manually operable switch foractivating the motor and/or pump, the switch is preferably implantedsubcutaneously so as to be operable from outside the patient's body.

Energy Source/Energy Transmission

As mentioned before, an energy source, possibly comprising an energystorage means, may be implanted inside the patient's body for supplyingat least one energy consuming part with energy.

Furthermore, an energy transforming device for transforming wirelessenergy into electric energy may also be implanted. Alternatively or inaddition thereto, galvanic coupling elements may be implanted fortransmitting energy to the energy consuming part in contacting fashion.

Control Unit

Also, as mentioned before, at least a part of a control unit may beimplanted to directly or indirectly control one or more elements of theflow control device.

Where the control unit comprises a manually operable switch foractivating the control unit, the switch is preferably implantedsubcutaneously so as to be operable from outside the patient's body.

Sensor

As mentioned before, one or more physical and/or functional parametersensors may be implanted to directly or indirectly sense physical and/orfunctional parameters inside the patient and in the system implantedinside the patient. Where the sensor is a pressure sensor, it may beplaced in the reservoir or intestine so as to sense the pressure withinthe reservoir or intestine, respectively. Where the sensor is a tensionsensor, it may be placed in contact with the reservoir or intestine soas to sense an expansion of the reservoir or intestine, respectively.Where the sensor is a movement sensor, it may be placed in contact withthe intestine so as to sense movement of the intestine. The functionalsensor may be adapted to measure at least one of the followingfunctional parameters of the system: an electrical parameter such asvoltage, current or energy balance or a stimulation parameter inrelation to the system.

Use

Once the system according to the invention has been properly installed,the flow control device can be used for emptying the reservoir implantedin the patient.

Exit and Entry Valve

More specifically, where the flow control device comprises an exit valvepreventing intestinal contents flow from the reservoir in its closedposition, the method of use comprises the steps of opening the exitvalve and then emptying the reservoir. Where in addition to the exitvalve an entry valve is provided allowing intestinal contents to flowtowards the reservoir in its open position, the method further comprisesthe step of closing the entry valve before emptying the reservoir.

According to one embodiment, the patient's intestine will be constrictedby means of the exit valve so as to prevent intestinal contents flowthrough the constricted intestine section while the reservoir is not tobe emptied. In addition, the patient's intestine may be constricted bymeans of the entry valve so as to prevent intestinal contents flowthrough the constricted intestine section while the reservoir is to beemptied. In this case the artificial reservoir is connected to a lateralopening in the patient's intestine wall, a single opening of thereservoir. An exit valve and preferable also an exit valve are arrangedat the patient's intestine upstream and downstream of the reservoir. Astomy exiting the patient's abdominal wall may be surgically createdfrom the patient's small or large intestine or connected to the anus orattached tissue.

As mentioned before, the step of constricting may comprise the step ofelectrically stimulating muscle or neural tissue of the intestinesection to cause at least partial contraction of the intestine section,preferably by applying electric pulses to the intestine section. Morepreferably, different portions of the intestine section may bestimulated over time. This specifically allows for stimulating, overtime, the different portions of the intestine section in a wave likemanner in a direction opposite to natural intestinal contents flow,thereby supporting the closing function of the valve.

As mentioned before, constriction may also be achieved by mechanicallyconstricting the intestine section at least partly. Where this iscombined with electrically stimulation, it is preferred that the stepsof mechanically constricting and electrically stimulating are performedon the same intestine section. More specifically, in order to empty thereservoir intestinal contents along the intestine section can be pumpedby, over time, electrically stimulating different portions of theintestine section in a wave like manner in a direction of naturalintestinal contents flow, when said mechanical constriction of theintestine section is released.

Where a valve, in particular the exit valve, comprises a hydrauliccompartment, the method of use may involve the step of filling oremptying the compartment with hydraulic fluid in order to change itsopen-closed-state.

As mentioned before, in a simple embodiment, a conduit may be insertedfrom outside the patient's body into the intestine, thereby mechanicallyurging the exit valve to open, when emptying of the reservoir isdesired.

Pump

Emptying the reservoir by means of a pump may Involve the step of actingon a wall of the reservoir by means of the pump so as to reduce thereservoir's volume, thereby emptying the reservoir.

Where the pump and the reservoir are separate from each other and wherethe pump is furthermore implanted inside the patient's body outside thepatient's intestine and comprises at least one electrical stimulationdevice, the method of use may comprise the steps of electricallystimulating muscle or neural tissue of an intestine section by means ofthe stimulation device so as to cause at least partial contraction ofthe intestine section, preferably by applying electric pulses to theintestine section. Again, the step of emptying the reservoir maycomprise pumping intestinal contents along the intestine section by,over time, stimulating the different portions of the intestine sectionin a wave like manner in a direction of natural intestinal contentsflow.

The intestinal contents may likewise be pumped along the intestinesection by, over time, constricting different portions of an intestinesection in a wave like manner in the direction of natural intestinalcontents flow by means of a constriction device which is adapted to atleast partly constrict the intestine section mechanically. Where thestimulation device is combined with such constriction device, pumping ofthe intestinal contents along the intestine section by, over time,stimulating the different portions of the intestine section in a wavelike manner in a direction of natural intestinal contents flow may beperformed, while constriction of the intestine section caused by theconstriction device is released at the respective portions.

The pump may be activated by manually operating a subcutaneouslyarranged actuator from outside the patient's body.

Where a conduit is inserted from outside the patient's body into theintestine, thereby mechanically urging the exit valve to open whenemptying the reservoir and where such conduit provides a flow passage toan external collecting device comprising a suction pump, the method ofuse further comprises the step of emptying the reservoir by means of thesuction pump.

Motor

The suction pump may preferably be driven by means of a motor. Also, atleast the exit valve is preferably driven between its closed and openpositions by means of at least one motor implanted in the patient'sbody. Similarly, the pump is preferably driven by means of a motorimplanted in the patient's body.

In either case, the motor is preferably activated from outside thepatient's body by operating a subcutaneously arranged switch.

Energy

As mentioned before, energy may be transmitted from outside thepatient's body to at least one implanted energy consuming part of thesystem, preferably in the form of wireless energy. This may involve thefollowing additional steps:

transforming the wirelessly transmitted energy into electric energy bymeans of an energy transforming device,

storing the transformed energy in an energy storage means, and

supplying the stored energy from the energy storage means to at leastone implanted energy consuming part of the system.

Again, energy may be supplied wirelessly from the storage means to theenergy consuming part.

Preferably, at least part of the wirelessly transmitted energy istransformed into electric energy and used for the energy consuming partof the system as said part of the wirelessly transmitted energy istransformed into the electric energy.

Control

Where a first part of a control unit for controlling at least one energyconsuming part of the system is implanted inside the patient's body, themethod of use may further comprise the step of using the external secondpart of the control unit to transmit data to the implanted first part ofthe control unit. Preferably, the data are transmitted to the implantedfirst part of the control unit in the same manner as energy istransmitted to the implanted energy consuming part. More particularly,the data are preferably transmitted wirelessly to the implanted firstpart of the control unit. This may involve a wireless control signal.

For instance, the implanted first part of the control unit can beprogrammed via the external second part of the control unit.Furthermore, a feedback signal may be transmitted from the implantedfirst part of the control unit to the external second part of thecontrol unit.

Sensor

Where one or more of the afore-mentioned sensors are provided, themethod of use may comprise the step of sensing a physical parameter inthe patient's body and/or a functional parameter of the system in thepatient's body, such as one or more of the following parameters: apressure within the reservoir, a pressure within the patient'sintestine, an expansion of the reservoir, a distension of an intestinalwall of the patient's intestine, a pressure against a part of the systemsuch as the reservoir, a distension of a part of the system such as awall of the reservoir, an electrical parameter such as voltage, currentor energy balance, a position or movement of a movable part of thesystem, any stimulation parameter in relation to the system.

A signal, such as a sound signal or a visual signal, may be providedwhen a value for the physical parameter sensed is beyond a predeterminedthreshold value.

Intestinal Disorder

“Artificial Intestine Section with Wirelessly Charged Accumulator”

Another object of the present invention is to provide an improved systemand method for treating a patient having a disorder related to thepatient's intestine.

Artificial Intestine Section with Wirelessly Charged Accumulator

An intestinal disorder treatment system according to the invention fortreating a patient having a disorder related to the patient's intestinecomprises an artificial intestine section adapted to being implantedinside a patient's body along with an accumulator for accumulatingenergy. The intestine section of the present invention has a first openend portion and a second open end portion in flow communication with oneanother, wherein at least the first open end portion and possibly alsothe second open end portion is adapted to being connected to asurgically created opening in the patient's intestine. Furthermore, theaccumulator is adapted to be charged wirelessly with energy and to bearranged so as to supply energy directly or indirectly to at least oneenergy consuming part of said artificial intestine section.

Lateral Connection to Intestine

Preferably, at least the first open end portion and possibly also thesecond open end portion of the artificial intestine section is adaptedto being connected to a lateral opening surgically created in a wall ofthe patient's intestine. Thus, rather than connecting the artificialintestine section to the cross-sectional end of the patient's intestine,it is connected to a lateral opening in the patient's intestinal wall,and for this purpose the respective open end portion of the artificialintestine section is specifically adapted.

By connecting the artificial intestine section laterally to theintestine, forces caused by the peristaltic movement of the intestineand acting on the artificial intestine section of the intestine arelargely avoided. More specifically, where the artificial intestinesection is connected to the cross-sectional opening of the intestine,the peristaltic waves of the intestine tend to pull the intestine off ofthe connection between the intestine and the artificial intestinesection. As compared to this, where the artificial intestine section isattached to an opening in the lateral wall of the intestine, theperistaltic waves pass the artificial intestine section substantiallywithout any impact on the connection between the intestinal wall and theartificial intestine section.

Structure of Lateral Attachment

In order to securely attach the artificial intestine section to thelateral opening, at least the first open end portion may comprise ashoulder portion formed around the end portion for lateral connection tothe patient's intestinal wall. Preferably, at least a part of theshoulder portion extends laterally from the artificial intestine sectionby 3 mm to 20 mm. Furthermore, the shoulder portion preferably has acurved cross section, so as to generally conform to the intestinal wallwhen laterally attached thereto. An open end portion adapted in this waycan advantageously be attached to the intestinal wall from the outsidethereof.

According to an improved embodiment, the shoulder portion may be splitinto an upper and a lower shoulder portion with a gap between the upperand lower shoulder portions for accommodating Intestinal wall tissuetherein. The lower shoulder portion, if suitably adapted, can then beplaced inside the patient's intestine through the surgically createdlateral wall opening, whereas the upper shoulder portion will be placedoutside the intestinal wall.

In order to allow the lateral wall opening to be easily stretched overthe lower shoulder portion when the lower shoulder portion is advancedthere through and yet in order to have a large contact area between theintestinal wall and the shoulder portion, the upper shoulder portion maybe made larger than the lower shoulder portion. Thus, the surface areaof the upper shoulder portion contacting the intestinal wall is alsolarger than the surface area of the lower shoulder portion contactingthe intestinal wall.

The open end portion for lateral connection to the patient's intestinalwall may be adapted to being connected to the patient's intestinal wallby gluing. For instance, it may have a particular rough surfacestructure for the glue to better adhere. Also, the open end portion maybe adapted to being connected to the patient's intestinal wall bysewing. For instance, a certain area of the shoulder portion may beperforated for stitching through the perforations or may be made from amaterial which is easy to penetrate with a needles. Similarly, the openend portion may specifically be adapted to being connected to thepatient's intestinal wall by stapling.

Frontal Connection to Intestine

While it is generally preferred to connect the first and possibly alsothe second open end portion of the artificial intestine sectionlaterally to an opening in the patient's intestinal wall, it is as wellpossible to adapt the open end portion for being connected to across-sectional opening surgically created in the patient's intestine.

Structure of Frontal Attachment (Bulge/Sleeve)

In this case, the open end portion of the artificial intestine sectionpreferably comprises

a conduit having an outer surface with at least one bulge extendingoutwardly from the conduit's outer surface in a circumferentialdirection of the conduit about at least a part of the conduit'scircumference, and

a blocking ring loosely fitting over the outer surface of the conduitwith a clearance between the outer surface and the blocking ring formounting intestinal tissue within the clearance, said blocking ringhaving an inner cross sectional diameter which is smaller than orsubstantially identical to an outer cross sectional diameter of the atleast one bulge so as to prevent the blocking ring from slipping overthe bulge when intestinal tissue is mounted within the clearance.

The artificial intestine section may then be affixed to thecross-sectional opening of the intestine part by inserting theartificial intestine section having a bulge formed on the outsidethereof into the cross-sectional opening of the intestine part so thatthe intestine part extends over the bulge from one side of the bulge andadvancing a blocking ring over the intestine part towards the bulge fromthe respective other side of the bulge such that the intestine part islocated intermediate the outer surface of the artificial intestinesection and the blocking ring.

Alternatively, the open end portion may comprise a conduit having anouter surface and a flexible sleeve adapted to axially extend andclosely fit around at least part of said outer surface of the conduit.The flexible sleeve can be mounted on said outer surface either foldedor rolled upon itself or so as to be foldable upon itself. In eithercase, the open end portion of the artificial intestine section may thenbe affixed to the cross-sectional opening of the intestine part byinserting the open end portion of the artificial intestine section intothe cross-sectional opening of the intestine part and placing theflexible sleeve so as to extend over both the intestine part and openend portion of the artificial intestine section such that the intestinepart is located intermediate the sleeve and the outer surface of theartificial intestine section.

Where the flexible sleeve is mounted on the outer surface of the openend portion of the artificial intestine piece so as to be foldable uponitself, the step of placing the flexible sleeve so as to extend overboth the intestine part and open end portion of the artificial intestinesection comprises folding the flexible sleeve upon itself such that theintestine part is located intermediate the folded sleeve.

The bulge and sleeve may also be provided on one conduit so as to beused in combination.

The afore-mentioned conduit of the artificial intestine section with asleeve or with a bulge serve to improve the strength of the connectionagainst axial forces which may e.g. result from the peristaltic movementof the Intestine and tend to pull on the intestine.

Furthermore, the conduit of the open end portion preferably comprises amultilayer material. For instance, it is advantageous when the open endportion comprises a porous ingrowth layer that allows ingrowth of livingtissue. The ingrowth layer may have a net-like structure and is mostpreferably made from Dacron®.

Through-Flow Arrangement

Straight Connection/by-Pass Connection

According to the afore-described structures of the first and second openend portions of the artificial intestine section, it is possible toconnect both the first and second open end portions to a surgicallycreated cross-sectional opening in the patients intestine, so as to forman intermediate intestine section, or to connect both the first andsecond open end portions to a surgically created lateral opening in awall of the patient's intestine, so as to form a by-pass intestinesection.

Stoma/Anus Connection

Alternatively, the second open end portion may be adapted to beingconnected to an surgically created stoma or to the patient's rectum oranus or to tissue adjacent the patient's anus, so as to form anintestine end section.

Downstream Connection to Residual Intestine

Further alternatively, the second open end portion may be adapted tobeing connected to a portion of the patient's small intestine or to aportion of the patients large intestine, as the case may be, and thisportion of the patient's intestine may then lead to the surgicallycreated stoma or to the patient's rectum or anus or to tissue adjacentthe patient's anus.

Material

Preferably, at least the first open end portion is made from abiocompatible material. The biocompatible material of the open endportion may comprise at least one material of the following group ofmaterials: titanium, stainless steel, ceramics, biocompatible polymermaterial. More specifically, the biocompatible polymer material maycomprise at least one polymer of the following group of polymers:polytetrafluoroethylene, silicone, polyurethane, expandedpolytetrafluoroethylene (ePTFE).

Intest. Content Interacting Device as an Energy Consuming Part

In a preferred embodiment, the at least one energy consuming part of theartificial intestine section comprises at least one element adapted todirectly or indirectly interact with intestinal contents contained inthe artificial intestine section between the first and second open endportions thereof.

Flow Control Device as an Energy Consuming Part

In a more advanced embodiment, the at least one element may comprise aflow control device adapted to control flow of intestinal contents fromthe artificial intestine section through the second open end portion.The flow control device is preferably adapted to prevent flow ofintestinal contents from the artificial intestine section through thesecond open end portion.

Exit Valve as Flow Control Device

The flow control device preferably comprises at least one valve,including an exit valve preventing intestinal contents flow through thesecond open end portion in its closed position. Preferably, the exitvalve is a normally closed valve so that no energy is needed to keep thevalve closed during the system's inactive periods.

Entry Valve as an Additional Part of the Flow Control Device

In addition, the flow control device may comprise an entry valveallowing intestinal contents to flow towards the reservoir in its openposition. This can be advantageous particularly during the emptying ofthe reservoir, when the entry valve should be closed. Therefore, theentry valve is preferably a normally open valve. Accordingly, the exitvalve and the entry valve are preferably adapted to cooperate such thatwhen one of the two valves is closed, the respective other valve isopen, and vice versa.

Valve Types

As regards the various valve types that may be employed, the at leastone valve may e.g. comprise a compartment with a variable volume adaptedto open and close the valve by changing the compartment's volume.Advantageously, the at least one valve comprises at least one passagefor filling and emptying the compartment with hydraulic fluid. Thecompartment preferably has at least one flexible wall defining anopening for a conduit to pass through, the opening being adapted toclose upon increase of the compartment's volume.

According to a different embodiment, the at least one valve may be aflap valve. The flap valve may for instance comprise a rotatable disc.

Extra Valve Separate from Artificial Intestine Piece

While the valve or valves preferably make an integral part of theartificial intestine section, the artificial intestine section mayfurther comprise one or more extra valves adapted to control flow ofintestinal contents in a natural section of the patient's intestineupstream and/or downstream the artificial intestine section. The extravalve may be rigidly connected to the artificial section but may as wellform a completely separate part. The extra valve is adapted to beingimplanted inside the patient's body outside a section of the patient'snatural intestine and comprises at least one element adapted to act onthe natural intestine section from the outside thereof so as to preventintestinal contents flow through the natural intestine section. Thisvalve arrangement does not require any surgery on the respective part ofthe natural intestine when the valve is implanted.

The extra valve may comprise at least one electrical stimulation deviceadapted to electrically stimulate muscle or neural tissue of anintestine section so as to cause at least partial contraction of thenatural intestine section. This is a very gender way of constricting theintestine. The stimulation device preferably comprises at least oneelectrode adapted to apply electric pulses to the natural intestinesection.

It is particularly advantageous to make use of a stimulation devicewhich is adapted to stimulate different portions of the intestinesection over time. Thus, different portions of the intestine section canbe constricted by stimulation at different times in any predeterminedstimulation pattern, thereby giving the intestine portions currently notstimulated time to recover and, thus, improving the blood circulation inthe respective intestine section.

Furthermore, the stimulation device can specifically be adapted tostimulate, over time, the different portions of the intestine section ina wave like manner in a direction opposite to natural intestinalcontents flow. As a result, the valve counteracts the natural intestinalcontents flow, thereby improving the valve's closing function.

Alternatively, or preferably in addition to the stimulation device, theat least one valve may comprise a constriction device implanted in thepatient's body for at least partly constricting the natural intestinesection mechanically from outside the natural intestine section. Wherethe stimulation device is combined with the constriction device, thestimulation device and the constriction device preferably act on thesame intestine section. In that case, it is advantageous if theconstriction device in its normal condition constricts the naturalintestine section only partly, in order not to damage the intestine overtime. Complete constriction and, thus, closing of the intestine may thenbe obtained by additionally stimulating the natural intestine section ina manner as described before.

In addition, when constriction of the intestine section caused by theconstriction device is released, the stimulation device may, ifaccordingly adapted, be used to pump intestinal contents along thenatural intestine section by, over time, stimulating the differentportions of the natural intestine section in a wave like manner in adirection of natural intestinal contents flow. In this situation, thevalve may incorporate the additional function of a pump for activelysupporting the discharge of feces from the human body.

Pump as an Energy Consuming Part

The at least one energy consuming part of the artificial intestinesection may comprise a pump for advancing intestinal contents throughthe second open end portion to outside the artificial intestine section.

Pump with Reservoir

In addition to the pump, the artificial intestine section may comprise areservoir between the first and second open end portions for receivingand temporarily collecting therein intestinal contents supplied throughthe first open end portion. In this case, the pump is preferably adaptedfor emptying the reservoir through the second open end portion. Avariety of different structures may be realized.

For instance, the reservoir may be formed by a bellow, said bellowhaving an end wall closing the bellow at one end thereof. The end wallmay then make part of the pump such that a volume of the bellow isreduced upon advancement of said end wall. Preferably, bellow is made ofa resilient material so as to urge the bellow into a normally expandedposition.

In another embodiment, the pump may comprise a movable piston, with afront end of the piston extending into the reservoir such that a volumeof the reservoir is reduced upon advancement of the piston. Preferably,the piston is spring loaded so as to urge the piston into a normallyretracted position.

Alternatively, the pump may be adapted for being permanently arrangedinside the reservoir.

In a further alternative, the reservoir may have a flexible wall and thepump is adapted for emptying the reservoir by squeezing the reservoir.In this case, the pump may e.g. include a constriction device adapted toalternately constrict and release sections of the reservoir so as topump intestinal contents along the reservoir by, over time, constrictingdifferent sections of the reservoir in a wave like manner. Morespecifically, the reservoir may have a tube-like form and a roller pumpmay be used as the pump acting on the tube-like reservoir from theoutside thereof.

Motor as an Energy Consuming Part

Where the valves or pump or any other energy consuming part of theartificial intestine section is not or not only manually drivable, theartificial intestine section may comprise at least one motor arrangedfor automatically driving at least one energy consuming part of theartificial intestine section. The motor is preferably arranged to bedriven by electric or electromagnetic energy.

A motor in the sense of the present invention is a device thattransforms energy other than mechanical energy into mechanical energy.While a pump in the sense of the present invention is a device foradvancing liquid or pasty material, a pump may at the same time be amotor in certain circumstances, such as where the transformation ofenergy into mechanical energy causes advancement of the liquid or pastymaterial without any intervening mechanical means such as a piston,bellow or the like.

For instance, the at least one motor can be arranged for driving atleast one of the valve or valves, respectively, between its closed andopen position. Also, the at least one motor can be arranged for drivingthe pump.

A manually operable switch may be provided for activating the at leastone motor, the switch being preferably arranged for subcutaneousimplantation so as to be operable from outside the patient's body.

Energy Transmission

Where energy is not transmitted wirelessly, galvanic coupling elementsmay be provided at least between the accumulator and the energyconsuming part, in particular the motor, for transmitting energy to themotor in contacting fashion.

The energy may alternatively be transmitted wirelessly from theaccumulator to the motor. Thus, the energy source may comprise awireless energy transmitter adapted to wirelessly transmit energy fromthe accumulator to the energy consuming part.

Preferably, in order to reduce the number of parts and possibly increasethe system's efficiency, the energy consuming part, in particular themotor, can be adapted to directly transform the wirelessly transmittedenergy from the accumulator into kinetic energy. In the alternative, theenergy consuming part will have to comprise a transforming device fortransforming the wirelessly transmitted energy from the accumulator intoelectric energy.

Similarly, the system preferably comprises an implantable energytransforming device for transforming the wirelessly transmitted energyfrom outside the patient's body into energy to be stored in theaccumulator of the implanted system and further comprises a wirelessenergy transmitter adapted to wirelessly transmit energy from outsidethe patient's body to said implantable energy transforming device.

It is further preferred to set up the system such that the energyconsuming part is driven with the electric energy, as said energytransforming device transforms the wireless energy into the electricenergy.

The energy transmitter can be adapted to generate an electromagneticfield, a magnetic field or an electrical field. The wireless energy maybe transmitted by the energy transmission device by at least onewireless signal. More specifically, the energy transmitter may beadapted to transmit the energy by at least one wireless energy signal,which may comprise an electromagnetic wave signal, including at leastone of an infrared light signal, a visible light signal, an ultra violetlight signal, a laser signal, a microwave signal, an X-ray radiationsignal, and a gamma radiation signal. Also, the wireless energy signalmay comprise a sound or ultrasound wave signal. Furthermore, thewireless energy signal may comprise a digital or analog signal or acombination thereof.

Energy Transmission Feedback

A feedback subsystem, which can make part of a control device describedsubsequently, can advantageously be provided to wirelessly send feedbackinformation related to the energy to be stored in the accumulator frominside the human body to the outside thereof. The feedback informationis then used for adjusting the amount of wireless energy transmitted bythe energy transmitter. Such feedback information may relate to anenergy balance which is defined as the balance between an amount ofwireless energy received inside the human body and an amount of energyconsumed by the at least one energy consuming part. Alternatively, thefeedback information may relate to an energy balance which is defined asthe balance between a rate of wireless energy received inside the humanbody and a rate of energy consumed by the at least one energy consumingpart.

Accumulator

The accumulator preferably comprises a rechargeable battery. It mayalternatively or in addition comprise a capacitor. The accumulator maybe adapted for being implanted inside the patient's body either fixedlyconnected to the artificial intestine section or distant to theartificial intestine section.

Primary Energy Source

A primary energy source may be provided for charging the accumulatorwith energy from outside the patient's body. The primary energy sourceis preferably adapted to being mounted on the patient's body.

Control Unit

It is advantageous to provide a control unit adapted to directly orindirectly control one or more elements of the system, such as forcontrolling opening of the exit valve and/or closing of the entry valve,in particular in a manner such that when one of the two valves isclosed, the respective other valve is open, and vice versa. The controlunit can also be adapted to control actuation of the pump.

The control unit is preferably operable by the patient, e.g.particularly in order to empty the reservoir.

At least part of the control unit may be adapted to be implantable inthe patients body. For instance, a manually operable switch may beprovided for activating the control unit, the switch preferably beingarranged for subcutaneous implantation so as to be operable from outsidethe patient's body. Also, the control unit may comprise a first partadapted for implantation in the patient's body and a second part adaptedto cooperate with the first part from outside the patient's body. Inthis case, the control unit can be adapted to transmit data from theexternal second part of the control unit to the implanted first part ofthe control unit in the same manner as energy is transmitted by saidwireless energy transmitter from outside the patients body to saidimplantable energy transforming device.

That is, the second part of the control unit may be adapted towirelessly transmit a control signal to the implantable first part ofthe control unit for controlling the at least one energy consuming partfrom outside the patient's body. Also, the implantable first part of thecontrol unit may be programmable via the second part of the controlunit. Furthermore, the implantable first part of the control unit may beadapted to transmit a feedback signal to the second part of the controlunit.

Sensor

Furthermore, a physical parameter sensor adapted to directly orindirectly sense a physical parameter of the patient can be provided.The physical parameter sensor may be adapted to sense at least one ofthe following physical parameters of the patient: a pressure within theartificial intestine section, a pressure within the patient's naturalintestine, an expansion of the artificial intestine section, adistension of an intestinal wall of the patient's natural intestine, amovement of the patient's intestinal wall.

Similarly, a functional parameter sensor adapted to directly orindirectly sense a functional parameter of the system can be provided,wherein the functional parameter sensor may be adapted to sense at leastone of the following functional parameters of the system: a pressureagainst a part of the system such as the artificial intestine section, adistension of a part of the system such as a wall of the artificialintestine section, an electrical parameter such as voltage, current orenergy balance, a position or movement of a movable part of the system.

Preferably, an indicator is coupled to the sensor or sensors, theindicator being adapted to provide a signal when a sensor senses a valuefor the parameter beyond a predetermined threshold value. The sensorsignal may comprise at least one of the following types of signals: asound signal, a visual signal.

Method of Treatment (Implantation)

The invention does not only relate to the system described above, butalso to a method of treating a patient having a disorder related to thepatient's intestine, more specifically to a method of implanting thesystem and to a method of using the system once it is installed on thepatient.

Accordingly, a surgical method of treating a patient according to theinvention comprises the steps of:

cutting the patient's skin and abdominal wall,

dissecting an area of the patient's intestine,

surgically creating at least one opening in the dissected intestinalarea so as to create an artificial intestinal opening,

providing an artificial intestine section having a first open endportion and a second open end portion in flow communication with oneanother and affixing the first open end portion to the artificialintestinal opening so as to be in flow communication therewith,

providing an accumulator adapted to be charged wirelessly with energyfrom outside the patient's body and arranging the accumulator inside thepatient's body so as to allow for supplying energy directly orindirectly from the accumulator to at least one energy consuming part ofsaid artificial intestine section, and

suturing the abdominal wall and skin.

A corresponding laparoscopic surgical method of treating a patientcomprises the steps of:

making a small opening in the patient's skin and abdominal wall,

introducing a needle in the abdominal cavity,

inflating the abdominal cavity with gas,

inserting at least one trocar into the cavity,

introducing a camera through the trocar,

inserting at least one dissecting instrument preferably through a secondtrocar,

dissecting an area of the intestine,

surgically creating at least one opening in the dissected intestinalarea so as to create an artificial intestinal opening,

providing an artificial intestine section having a first open endportion and a second open end portion in flow communication with oneanother and affixing the first open end portion to the artificialintestinal opening so as to be in flow communication therewith,

providing an accumulator adapted to be charged wirelessly with energyfrom outside the patient's body and arranging the accumulator inside thepatient's body so as to allow for supplying energy directly orindirectly from the accumulator to at least one energy consuming part ofsaid artificial intestine section, and

extracting the instruments, camera and trocar, and in relation thereto

suturing, if necessary, the abdominal wall and permanently closing theskin.

Where the accumulator is provided fixedly connected to the artificialintestine section, it may be arranged inside the patient's body alongwith the artificial intestine section. Alternatively, where theaccumulator is provided separate from the artificial intestine section,it may be implanted inside the patient's body distant to the artificialintestine section.

Where energy is not transferred wirelessly from the accumulator to theenergy consuming part of the artificial intestine section, theaccumulator may be galvanically coupled to the artificial intestinesection for transmitting the energy to the at least one energy consumingpart of the artificial intestine section in contacting fashion.

Dividing the Intestine

The method of implantation may involve dividing the intestine so as toobtain one or two cross-sectional opening of the intestine. The methodof implantation may then comprise the following additional steps:

dissecting a portion of the dissected intestinal area downstream of theintestinal opening to be created, such that intestinal mesenteryconnected to the dissected portion is opened in such a way that supplyof blood through the mesentery to the dissected intestinal area ismaintained as far as possible on both sides of the dissected portion,and

dividing the patient's intestine in the dissected portion so as tocreate an upstream part of the intestine with an artificial intestinalopening being formed as a cross-sectional opening at the downstream sidethereof and a downstream part of the intestine with an artificialintestinal opening being formed as a cross-sectional opening at theupstream side thereof, wherein the mesentery maintains a tissueconnection between the upstream and downstream intestine parts.

Frontal Connection at Upstream End

At least the first open end portion of the artificial intestine sectioncan then be affixed to the cross-sectional downstream opening of theupstream intestine part so as to be in flow communication therewith.

Frontal Connection at Downstream End

Also, the second open end portion of the artificial intestine sectioncan be affixed to the cross-sectional upstream opening of the downstreamintestine part so as to be in flow communication therewith.

Frontal Connection at Both Ends

Where the artificial intestine piece is to be connected to bothcross-sectional openings of the divided intestine, the method maycomprise the two afore-mentioned steps in combination, i.e. affixing thefirst open end portion of the artificial intestine section to thecross-sectional downstream opening of the upstream intestine part so asto be in flow communication therewith and affixing the second open endportion of the artificial intestine section to the cross-sectionalupstream opening of the downstream intestine part so as to be in flowcommunication therewith.

Frontal Connection Upstream, Lateral Connection Downstream

Alternatively, the second open end portion of the artificial intestinesection may be connected to a lateral opening in the wall of thedownstream intestine part, in which case the method of implantation maycomprise the following steps:

closing the cross-sectional opening at the downstream side of theupstream intestine part,

surgically creating an opening in a wall of the upstream intestine partso as to create a lateral intestinal opening therein,

affixing the first open end portion of the artificial intestine sectionto the lateral intestinal opening of the upstream intestine part so asto be in flow communication therewith and

affixing the second open end portion of the artificial intestine sectionto the cross-sectional upstream opening of the downstream intestine partso as to be in flow communication therewith.

Sleeve/Bulge Connector for Frontal Connection

The step of affixing the open end portion of the artificial intestinesection to the cross-sectional opening of the intestine part preferablycomprises:

inserting the open end portion of the artificial intestine section intothe cross-sectional opening of the intestine part, and

placing a flexible sleeve so as to extend over both the intestine partand open end portion of the artificial intestine section such that theintestine part is located intermediate the sleeve and the outer surfaceof the artificial intestine section.

Where the flexible sleeve is mounted on the outer surface of the openend portion of the artificial intestine piece so as to be foldable uponitself and wherein the step of placing the flexible sleeve so as toextend over both the intestine part and open end portion of theartificial intestine section comprises folding the flexible sleeve uponitself such that the intestine part is located intermediate the foldedsleeve.

Alternatively, or in addition, the step of affixing the open end portionof the artificial intestine section to the cross-sectional opening ofthe intestine part comprises:

inserting the artificial intestine section having a bulge formed on theoutside thereof into the cross-sectional opening of the intestine partso that the intestine part extends over the bulge from one side of thebulge, and

advancing a blocking ring over the intestine part towards the bulge fromthe respective other side of the bulge such that the intestine part islocated intermediate the outer surface of the artificial intestinesection and the blocking ring.

The afore-mentioned open end portion of the artificial intestine sectionwith a sleeve or with a bulge serve to improve the strength of theconnection against axial forces which may e.g. result from theperistaltic movement of the intestine and tend to pull on the intestine.The open end portion of the artificial intestine section may alsocombine a sleeve and a bulge.

Lateral Connection Upstream, Frontal Connection Downstream

It has been described above that the second open end portion of theartificial intestine section may be connected to a lateral opening inthe wall of the downstream intestine part while the first open endportion is connected to a cross-sectional opening of the upstreamintestine part. The connection can alternatively be made vice versa, inwhich case the method of implantation may comprise the following steps:

closing the cross-sectional opening at the upstream side of thedownstream intestine part,

surgically creating an opening in a wall of the downstream intestinepart so as to create a lateral intestinal opening therein,

affixing the second open end portion of the artificial intestine sectionto the lateral intestinal opening of the downstream intestine part so asto be in flow communication therewith and

affixing the first open end portion of the artificial intestine sectionto the cross-sectional downstream opening of the upstream intestine partso as to be in flow communication therewith.

Lateral Connection at Both Ends

Of course, it is also possible and even preferred to connect both openend portions of the artificial intestine piece to lateral openings inthe intestinal wall, in which case the method of implantation maycomprise the following steps:

closing the cross-sectional opening at the downstream side of theupstream intestine part,

surgically creating an opening in a wall of the upstream intestine partso as to create a lateral intestinal opening therein,

affixing the first open end portion of the artificial intestine sectionto the lateral intestinal opening of the upstream intestine part so asto be in flow communication therewith

closing the cross-sectional opening at the upstream side of thedownstream intestine part,

surgically creating an opening in a wall of the downstream intestinepart so as to create a lateral intestinal opening therein and

affixing the second open end portion of the artificial intestine sectionto the lateral intestinal opening of the downstream intestine part so asto be in flow communication therewith.

Lateral Connection at Both Ends without Dividing Intestine

It is also possible to connect both open end portions of the artificialintestine piece to lateral openings in the intestinal wall withoutdividing the intestine, in which case the step of surgically creating atleast one opening in the dissected intestinal area comprises the stepsof surgically creating a first opening in a wall of the intestine so asto create a first lateral intestinal opening and surgically creating asecond opening in the wall of the intestine at a location downstream ofthe first opening so as to create a second lateral intestinal opening,and the method of implantation then further comprises the steps of:

permanently closing the patients intestine at a location between thefirst and second lateral intestinal openings so as to form an upstreamintestinal part upstream said permanent closure and a downstreamintestinal part downstream said permanent closure.

affixing the first open end portion of the artificial intestine sectionto the first lateral intestinal opening and

affixing the second open end portion of the artificial intestine sectionto the second lateral intestinal opening.

Structure of Lateral Attachment

Where the open end portion of the artificial intestine section is to beaffixed to a lateral intestinal opening so as to be in flowcommunication therewith, this may comprise the step of connecting theafore-mentioned shoulder portion, which is formed around the open endportion, to the patient's intestinal wall so as to surround the lateralintestinal opening. In particular, the step of affixing the open endportion to the intestine may comprise attaching the shoulder portion tothe patient's outer intestinal wall.

Alternatively, where the shoulder portion is split into an upper and alower shoulder portion with a gap between the upper and lower shoulderportions, the step of affixing the open end portion of the artificialintestine section to the lateral intestinal opening comprises placingthe lower shoulder portion inside the patient's intestine and the uppershoulder portion outside the patient's intestine such that intestinalwall tissue is accommodated in the gap.

The step of affixing the open end portion of the artificial intestinesection to the lateral intestinal opening may comprise gluing, sewingand/or stapling the open end portion to the patient's intestinal wall.

Exit Through Stoma

As mentioned before, the downstream intestinal part may be connected toa surgically created stomy or to the patient's rectum or anus or totissue adjacent the patient's anus. In the case of a connection to astomy, this would involve the following steps:

cutting the patient's skin and abdominal wall so as to create an openingfor an intestinal stomy,

dissecting the area of the stomy opening,

dividing the intestine at a location downstream of the artificialintestine section so as to create an upstream natural intestine sectionhaving a cross-sectional opening at the downstream end thereof and adownstream natural intestine section,

dissecting the mesentery of the upstream natural intestine section inthe area of the cross-sectional opening thereof to prepare for creatingthe intestinal stomy,

advancing the downstream end of the upstream natural intestine sectionthrough the abdominal wall and skin, and

suturing the cross-sectional opening of the upstream natural intestinesection to the skin with the intestinal mucosa turned inside out,thereby achieving the intestinal stomy.

Exit Through Anus

In the case of a connection to the patient's anus or to tissue adjacentthe patient's anus, this would involve the following steps:

dividing the intestine at a location downstream of the artificialintestine section so as to create an upstream natural intestine sectionhaving a cross-sectional opening at the downstream end thereof and adownstream natural intestine section leading to the patient's anus,

dissecting the area of the patient's anus and surgically separating thedownstream natural Intestine section from the patient's anus, whereasthe steps of dividing the intestine and separating the intestine sectionleading to the patient's anus can alternatively be carried out inreversed order,

dissecting the mesentery of the upstream natural intestine section inthe area of the cross-sectional opening at the downstream end thereof toprepare for connecting the upstream natural intestine section to thepatient's anus or tissue adjacent the patient's anus,

advancing the downstream end of the upstream natural intestine sectionthrough the patient's anus, and

suturing the cross-sectional opening of the upstream natural intestinesection to the patient's anus or tissue adjacent the patient's anus.

Depending upon the circumstances, the step of dividing the intestine soas to form the upstream natural intestine section may be performedeither on the patient's small intestine or on the patient's largeintestine.

Intest. Content Interacting Device as an Energy Consuming Part (FlowControl Device/Exit Valve/Entry Valve/Pump/Reservoir)

As mentioned before, the artificial intestine section or system maycomprise at least one energy consuming part adapted to directly orindirectly interact with intestinal contents contained in the artificialintestine section between the first and second open end portionsthereof. This element will be implanted along with the artificialintestine section. As also mentioned before, the energy consuming partmay comprise a flow control device adapted to control flow of intestinalcontents from the artificial intestine section through the second openend portion.

Again, the flow control device may comprise an exit valve preventingintestinal contents flow through the second open end portion in itsclosed position and may additionally comprise an entry valve allowingintestinal contents to flow through the first open end portion into theartificial intestine section in its open position.

Alternatively or in addition, as also mentioned before, the flow controldevice may comprise a pump for advancing intestinal contents through thesecond open end portion to outside the artificial intestine section.

If a reservoir is provided between the first and second open endportions for receiving and temporarily collecting therein intestinalcontents supplied through the first open end portion, the pump may beadapted to empty the reservoir through the second open end portion.

Furthermore, where the pump comprises a manually operable switch foractivating the pump, the method of implantation may further comprise thestep of implanting the switch subcutaneously so as to be operable fromoutside the patient's body.

Motor

Again, at least one motor may be implanted along with the artificialintestine section and may be arranged for automatically driving one ormore energy consuming part of the flow control device. Where the motorcomprises a manually operable switch for activating the motor, themethod of implantation may further comprise the step of implanting theswitch subcutaneously so as to be operable from outside the patient'sbody.

Energy Transmission

Where energy is transmitted wirelessly, for instance from outside thepatient's body to inside the patient's body either to an energyconsuming part and/or more specifically to be stored in the accumulatoror from the accumulator to the energy consuming part, it may further benecessary to implant an energy transforming device for transforming thewireless energy into electric energy. Alternatively or in addition,galvanic coupling elements may be implanted, e.g. for transmittingenergy to the energy consuming part in contacting fashion from theimplanted energy source.

Accumulator

Preferably, at least one rechargeable battery is provided as theaccumulator. Alternatively or in addition thereto, at least onecapacitor may be provided as the accumulator.

Control Unit

Furthermore, as mentioned previously, at least a part of a control unitmay be implanted inside the patient's body adapted to directly orindirectly control one or more of the elements that have also beenimplanted in the patient's body. Where the control unit comprises amanually operable switch for activating the control unit, the method ofimplantation may further comprise the step of implanting said switchsubcutaneously so as to be operable from outside the patient's body.

Sensor

As mentioned before, one or more physical and/or functional parametersensors may be implanted to directly or indirectly sense physical and/orfunctional parameters inside the patient and in the system implantedinside the patient. Where the sensor is a pressure sensor, it may beplaced in the artificial intestine section or the patient's naturalintestine so as to sense the pressure within the artificial intestinesection or patients natural intestine, respectively. Where the sensor isa tension sensor, it may be placed in contact with the artificialintestine section or the patient's natural intestine so as to sense anexpansion of the artificial intestine section or patient's naturalintestine, respectively. Where the sensor is a movement sensor, it maybe placed in contact with the artificial intestine section or thepatient's natural intestine so as to sense movement of the artificialintestine section or patient's natural intestine, respectively. Thefunctional sensor may be adapted to measure at least one of thefollowing functional parameters: an electrical parameter such asvoltage, current or energy balance or a stimulation parameter inrelation to the system.

Use

Once the system according to the invention has been properly installedand where the at least one energy consuming part of the artificialintestine section comprises at least one element adapted to directly orindirectly interact with intestinal contents contained in the artificialintestine section between the first and second open end portionsthereof, the at least one element may be activated so as to interactwith the intestinal contents.

Exit and Entry Valve

Where the at least one element comprises an exit valve preventingintestinal contents flow from the artificial intestine section throughthe second open end portion in its closed position, the method of usemay further comprise the steps of opening the exit valve and thenremoving intestinal contents from the artificial intestine section.Furthermore, where the at least one element further comprises an entryvalve allowing intestinal contents to flow through the first open endportion into the artificial intestine section in its open position, themethod may further comprise the step of closing the entry valve beforeremoving intestinal contents from the artificial intestine section.

Pump

Where the at least one element interacting with intestinal contentsinside the artificial intestine piece comprises a pump, the method ofuse may further comprise the step of advancing intestinal contents fromthe artificial intestine section through the second open end portionthereof to outside the artificial intestine section by means of thepump. The pump may be activated by manually operating a subcutaneouslyarranged actuator from outside the patient's body.

Pump with Reservoir

More specifically, if the artificial intestine section comprises areservoir between the first and second open end portions for receivingand temporarily collecting therein intestinal contents supplied throughthe first open end portion, the step of advancing intestinal contents tooutside the intestine section may comprise operating the pump so as toempty the reservoir.

Where the reservoir is formed by a bellow, said bellow having an endwall closing the bellow at one end thereof and said end wall making partof the pump, the step of advancing the intestinal contents to outsidethe intestine section may comprise advancing the end wall so as toreduce a volume of the bellow.

Where the pump comprises a movable piston with a front end of the pistonextending into the reservoir, the step of advancing the intestinalcontents to outside the intestine section may comprise advancing thepiston so as to reduce a volume of the reservoir.

Where the reservoir has a flexible wall, the step of advancing theintestinal contents to outside the intestine section may comprisesqueezing the reservoir by means of the pump. For instance, the pump mayinclude a constriction device, in which case the step of advancing theintestinal contents to outside the intestine section may comprisealternately constricting and releasing sections of the reservoir so asto pump the intestinal contents along the reservoir by, over time,constricting different sections of the reservoir in a wave like manner.More specifically, the reservoir may have a tube-like form and the pumpcan be a roller pump acting on the tube-like reservoir from the outsidethereof.

Motor

Furthermore, where the at least one element interacting with intestinalcontents inside the artificial intestine piece comprises a motor, themethod of use may further comprise the step of driving at least the exitvalve between its closed and open positions and/or driving at least thepump by means of the motor. In either case, the motor is preferablyactivated by manually operating a subcutaneously arranged actuator fromoutside the patient's body.

Energy

Again, energy is to be transmitted wirelessly from outside the patient'sbody to the accumulator. Therefore, upon charging the accumulator withenergy, the method of use involves the following steps:

transmitting the energy wirelessly from outside the patient's body,

transforming the wirelessly transmitted energy into energy to be storedin the accumulator by means of an energy transforming device implantedin the patient's body, and

charging the accumulator with at least part of the transformed energy.

The method of use may then further involve the step of supplying energyfrom the accumulator to at least one implanted energy consuming part ofthe system, preferably wirelessly.

More preferably, at least part of the wirelessly transmitted energy istransformed into electric energy and used for the energy consuming partof the system, as said part of the wirelessly transmitted energy istransformed into the electric energy.

As mentioned before, the wireless energy can advantageously betransmitted by means of an electromagnetic field, a magnetic field or anelectrical field. More specifically, the energy may be transmitted by atleast one wireless energy signal, which may comprise an electromagneticwave signal, including at least one of an infrared light signal, avisible light signal, an ultra violet light signal, a laser signal, amicrowave signal, an X-ray radiation signal, and a gamma radiationsignal. Also, the wireless energy signal may comprise a sound orultrasound wave signal. Furthermore, the wireless energy signal maycomprise a digital or analog signal or a combination thereof.

Control

Where a first part of a control unit for controlling at least one energyconsuming part of the system is implanted inside the patient's body, themethod of use may further comprise the step of using the external secondpart of the control unit to transmit data to the implanted first part ofthe control unit. Preferably, the data are transmitted to the implantedfirst part of the control unit in the same manner as energy istransmitted to the implanted energy consuming part. More particularly,the data are preferably transmitted wirelessly to the implanted firstpart of the control unit. This may involve a wireless control signal.

For instance, the implanted first part of the control unit can beprogrammed via the external second part of the control unit.Furthermore, a feedback signal may be transmitted from the implantedfirst part of the control unit to the external second part of thecontrol unit.

Sensor

Where one or more of the afore-mentioned sensors are provided, themethod of use may comprise the step of sensing a physical parameter inthe patient's body and/or a functional parameter of the artificialintestine piece or system in the patient's body, such as one or more ofthe following parameters: a pressure within the artificial intestinesection, a pressure within the patient's natural intestine, an expansionof the artificial intestine section, a distension of an intestinal wallof the patient's natural intestine, a movement of the patient'sintestinal wall, a pressure against a part of the system such as theartificial intestine section, a distension of a part of the system suchas a wall of the artificial intestine section, an electrical parametersuch as voltage, current or energy balance, a position or movement of amovable part of the system.

A signal, such as a sound signal or a visual signal, may be providedwhen a value for the physical parameter sensed is beyond a predeterminedthreshold value.

Intestinal Disorder

“Artificial Intestine Section”

It is an object of the present invention to provide an improved systemand method for treating a patient having a disorder related to thepatient's intestine.

Laterally Connected Artificial Intestine Section

The present invention provides an artificial Intestine section adaptedto be implanted inside the patient's body. The artificial intestinesection of the present invention has a first open end portion and asecond open end portion in flow communication with one another, whereinat least the first open end portion is adapted to being connected to asurgically created lateral opening in a wall of the patient's intestine.Thus, rather than connecting the artificial intestine section to thecross-sectional end of the patient's intestine, it will be connected toa lateral opening in the patient's intestinal wall, and for this purposethe respective end portion of the artificial intestine section isspecifically adapted.

By connecting the artificial intestine section laterally to theintestine, forces caused by the peristaltic movement of the intestineand acting on the artificial intestine section of the intestine arelargely avoided. More specifically, where the artificial intestinesection is connected to the cross-sectional opening of the intestine,the peristaltic waves of the intestine tend to pull the intestine off ofthe connection between the intestine and the artificial intestinesection. As compared to this, where the artificial intestine section isattached to an opening in the lateral wall of the intestine, theperistaltic waves pass the artificial intestine section substantiallywithout any impact on the connection between the intestinal wall and theartificial intestine section.

The second open end portion of the artificial intestine section may beadapted to being connected to a surgically created stomy or to thepatient's rectum or anus or to tissue adjacent the patient's anus.Alternatively, since direct contact of the artificial intestine sectionwith the patient's skin may cause inflammation and might not beacceptable on the long run for many reasons, it is likewise possible toadapt the second open end portion of the artificial intestine section soas to being connected to a portion of the large intestine or to aportion of the small intestine, as the case may be, and to connect thatportion to the patient's rectum or anus or to tissue adjacent thepatient's anus or to use that portion for creating a stomy.

By-Pass Arrangement

Alternatively, both the first and second open end portions can beadapted to being connected to a surgically created lateral opening in awall of the patient's intestine.

Structure of Attachment

In order to securely attach the artificial intestine section to thelateral opening, at least the first open end portion may comprise ashoulder portion formed around the end portion for lateral connection tothe patient's intestinal wall. Preferably, at least a part of theshoulder portion extends laterally from the artificial intestine sectionby 3 mm to 20 mm. Furthermore, the shoulder portion preferably has acurved cross section, so as to generally conform to the intestinal wallwhen laterally attached thereto. An open end portion adapted in this waycan advantageously be attached to the intestinal wall from the outsidethereof.

According to an improved embodiment, the shoulder portion may be splitinto an upper and a lower shoulder portion with a gap between the upperand lower shoulder portions for accommodating intestinal wall tissuetherein. The lower shoulder portion, if suitably adapted, can then beplaced inside the patient's intestine through the surgically createdlateral wall opening, whereas the upper shoulder portion will be placedoutside the intestinal wall.

In order to allow the lateral wall opening to be easily stretched overthe lower shoulder portion when the lower shoulder portion is advancedthere through and yet in order to have a large contact area between theintestinal wall and the shoulder portion, the upper shoulder portion maybe made larger than the lower shoulder portion. Thus, the surface areaof the upper shoulder portion contacting the intestinal wall is alsolarger than the surface area of the lower shoulder portion contactingthe intestinal wall.

The open end portion for lateral connection to the patient's intestinalwall may be adapted to being connected to the patient's intestinal wallby gluing. For instance, it may have a particular rough surfacestructure for the glue to better adhere. Also, the open end portion maybe adapted to being connected to the patient's intestinal wall bysewing. For instance, a certain area of the shoulder portion may beperforated for stitching through the perforations or may be made from amaterial which is easy to penetrate with a needles. Similarly, the openend portion may specifically adapted to being connected to the patient'sintestinal wall by stapling.

Preferably, at least the first open end portion is made from abiocompatible material. The biocompatible material of the open endportion may comprise at least one material of the following group ofmaterials: titanium, stainless steel, ceramics, biocompatible polymermaterial. More specifically, the biocompatible polymer material maycomprise at least one polymer of the following group of polymers:polytetrafluoroethylene, silicone, polyurethane, expandedpolytetrafluoroethylene (ePTFE).

Also, at least the first open end portion preferably comprises amultilayer material. For instance, it is advantageous when the open endportion comprises a porous ingrowth layer that allows ingrowth of livingtissue. The ingrowth layer may have a net-like structure and is mostpreferably made from Dacron®.

Intestinal Content Interacting Device within Artificial IntestineSection

In a preferred embodiment, the artificial intestine section is adaptedto directly or indirectly interact with intestinal contents contained inthe artificial Intestine section between the first and second open endportions thereof.

Reservoir

In its simplest form, the at least one element of the artificialintestine section comprises an artificial reservoir between the firstand second open end portions for receiving and temporarily collectingtherein intestinal contents supplied through the first open end portion.

Flow Control Device

In a more advanced embodiment, the at least one element may comprise,possibly in addition to the reservoir, a flow control device adapted tocontrol flow of intestinal contents from the artificial intestinesection through the second open end portion. The flow control device ispreferably adapted to prevent flow of intestinal contents from theartificial intestine section through the second open end portion.

Exit Valve as Flow Control Device

The flow control device preferably comprises at least one valve,including an exit valve preventing intestinal contents flow through thesecond open end portion in its closed position. Preferably, the exitvalve is a normally closed valve so that no energy is needed to keep thevalve closed during the system's inactive periods.

Entry Valve as an Additional Part of the Flow Control Device

In addition, the flow control device may comprise an entry valveallowing intestinal contents to flow towards the reservoir in its openposition. This can be advantageous particularly during the emptying ofthe reservoir, when the entry valve should be closed. Therefore, theentry valve is preferably a normally open valve. Accordingly, the exitvalve and the entry valve are preferably adapted to cooperate such thatwhen one of the two valves is closed, the respective other valve isopen, and vice versa.

Valve Types

As regards the various valve types that may be employed, the at leastone valve may e.g. comprise a central opening which is normally closedby resilient means that can be urged apart mechanically by inserting aconduit through the central opening so as to open the central opening ofthe valve. In the simplest embodiment, the valve may be opened bymechanical force, such as by inserting a tube from outside the patient'sbody through the valve. The valve in this case can be a simplenon-return valve.

According to a more complex embodiment, the at least one valve maycomprise a compartment with a variable volume adapted to open and closethe valve by changing the compartment's volume. Advantageously, the atleast one valve comprises at least one passage for filling and emptyingthe compartment with hydraulic fluid. The compartment preferably has atleast one flexible wall defining an opening for the intestine or aconduit of the reservoir to pass through, the opening being adapted toclose upon increase of the compartment's volume.

According to a different embodiment, the at least one valve may be aflap valve permanently implanted inside the patient's intestine. Theflap valve may for instance comprise a rotatable disc.

Extra Valve Separate from Artificial Intestine Piece

While the valve or valves preferably make an integral part of theartificial intestine section, the artificial intestine section mayfurther comprise one or more extra valves adapted to control flow ofintestinal contents in a natural section of the patient's intestineupstream and/or downstream the artificial intestine section. The extravalve may be rigidly connected to the artificial section but may as wellform a completely separate part, in which case the artificial intestinesection and the extra valve together rather form a “system”. The extravalve is adapted to being implanted inside the patient's body outside asection of the patient's natural intestine and comprises at least oneelement adapted to act on the natural intestine section from the outsidethereof so as to prevent intestinal contents flow through the naturalintestine section. This valve arrangement does not require any surgeryon the respective part of the natural intestine when the valve isimplanted.

The extra valve may comprise at least one electrical stimulation deviceadapted to electrically stimulate muscle or neural tissue of anintestine section so as to cause at least partial contraction of thenatural intestine section. This is a very gender way of constricting theintestine. The stimulation device preferably comprises at least oneelectrode adapted to apply electric pulses to the natural intestinesection.

It is particularly advantageous to make use of a stimulation devicewhich is adapted to stimulate different portions of the intestinesection over time. Thus, different portions of the intestine section canbe constricted by stimulation at different times in any predeterminedstimulation pattern, thereby giving the intestine portions currently notstimulated time to recover and, thus, improving the blood circulation inthe respective intestine section.

Furthermore, the stimulation device can specifically be adapted tostimulate, over time, the different portions of the intestine section ina wave like manner in a direction opposite to natural intestinalcontents flow. As a result, the valve counteracts the natural intestinalcontents flow, thereby improving the valve's closing function.

Alternatively, or preferably in addition to the stimulation device, theat least one valve may comprise a constriction device implanted in thepatient's body for at least partly constricting the natural intestinesection mechanically from outside the natural intestine section. Wherethe stimulation device is combined with the constriction device, thestimulation device and the constriction device preferably act on thesame intestine section. In that case, it is advantageous if theconstriction device in its normal condition constricts the naturalintestine section only partly, in order not to damage the intestine overtime. Complete constriction and, thus, closing of the intestine may thenbe obtained by additionally stimulating the natural intestine section ina manner as described before.

In addition, when constriction of the intestine section caused by theconstriction device is released, the stimulation device may, ifaccordingly adapted, be used to pump intestinal contents along thenatural intestine section by, over time, stimulating the differentportions of the natural intestine section in a wave like manner in adirection of natural intestinal contents flow. In this situation, thevalve may incorporate the additional function of a pump for activelysupporting the discharge of feces from the human body.

Pump as Part of the Implantable Flow Control Device

The flow control device may comprise a pump for advancing intestinalcontents through the second open end portion to outside the artificialintestine section. Where the artificial intestine section comprises areservoir, the pump may be adapted for emptying the reservoir. A varietyof different structures may be realized.

For instance, the reservoir may be formed by a bellow, said bellowhaving an end wall closing the bellow at one end thereof. The end wallmay then make part of the pump such that a volume of the bellow isreduced upon advancement of said end wall. Preferably, bellow is made ofa resilient material so as to urge the bellow into a normally expandedposition.

In another embodiment, the pump may comprise a movable piston, with afront end of the piston extending into the reservoir such that a volumeof the reservoir is reduced upon advancement of the piston. Preferably,the piston is spring loaded so as to urge the piston into a normallyretracted position.

Alternatively, the pump may be adapted for being permanently arrangedinside the reservoir.

In a further alternative, the reservoir may have a flexible wall and thepump is adapted for emptying the reservoir by squeezing the reservoir.In this case, the pump may e.g. include a constriction device adapted toalternately constrict and release sections of the reservoir so as topump intestinal contents along the reservoir by, over time, constrictingdifferent sections of the reservoir in a wave like manner. Morespecifically, the reservoir may have a tube-like form and a roller pumpmay be used as the pump acting on the tube-like reservoir from theoutside thereof.

Motor

Where the valves or pump or any other element of the flow control deviceis not or not only manually drivable, at least one motor can be providedfor automatically driving at least one energy consuming part of the flowcontrol device. The motor is preferably arranged to be driven byelectric or electromagnetic energy.

A motor in the sense of the present invention is a device thattransforms energy other than mechanical energy into mechanical energy.While a pump in the sense of the present invention is a device foradvancing liquid or pasty material, a pump may at the same time be amotor in certain circumstances, such as where the transformation ofenergy into mechanical energy causes advancement of the liquid or pastymaterial without any intervening mechanical means such as a piston,bellow or the like.

For instance, the at least one motor can be arranged for driving atleast one of the valve or valves, respectively, between its closed andopen position. Also, the at least one motor can be arranged for drivingthe pump.

A manually operable switch may be provided for activating the at leastone motor, the switch being preferably arranged for subcutaneousimplantation so as to be operable from outside the patient's body.

Energy Source

The artificial intestine section may be combined with further componentsto form a system. The further components may be integrated in theartificial intestine section to be implanted along therewith or may beseparate from the artificial intestine section to be implantedseparately or not to be implanted at all.

The system may for instance comprise an energy source for supplyingenergy directly or indirectly to at least one energy consuming part ofthe system. Preferably, the energy source includes a battery or anaccumulator, such as one or more of a rechargeable battery and acapacitor, as an energy storage means. The energy storage means isadvantageously adapted for being implanted inside the patient's body,more preferably as a part of the artificial intestine section.

Wireless Energy Transmission

Energy is preferably transmitted wirelessly. Thus, where the energysource is provided for supplying energy directly or indirectly to atleast one energy consuming part of the system, the energy source maycomprise a wireless energy transmitter adapted to wirelessly transmitenergy from outside the patient's body to the at least one energyconsuming part. Alternatively, where the energy source includes abattery or an accumulator, in particular one which is implanted in thepatient's body, the energy source may comprise a wireless energytransmitter adapted to wirelessly transmit energy from outside thepatient's body to the energy storage means.

Energy Transmission Feedback

A feedback subsystem, which can make part of a control device describedsubsequently, can advantageously be provided to wirelessly send feedbackinformation related to the energy to be stored in the accumulator frominside the human body to the outside thereof. The feedback informationis then used for adjusting the amount of wireless energy transmitted bythe energy transmitter. Such feedback information may relate to anenergy balance which is defined as the balance between an amount ofwireless energy received inside the human body and an amount of energyconsumed by the at least one energy consuming part. Alternatively, thefeedback information may relate to an energy balance which is defined asthe balance between a rate of wireless energy received inside the humanbody and a rate of energy consumed by the at least one energy consumingpart.

Also, the transmission of energy from the energy storage means to the atleast one energy consuming part may be performed wirelessly by means ofan accordingly adapted wireless energy transmitter.

Preferably, in order to reduce the number of parts and possibly increasethe system's efficiency, the energy consuming part can be adapted todirectly transform the wirelessly transmitted energy into kineticenergy. Otherwise, it will be necessary to provide an implantable energytransforming device for transforming the wireless energy, preferablyinto electric energy. In this case, it is further preferred to set upthe system such that the energy consuming part is driven with theelectric energy, as said energy transforming device transforms thewireless energy into the electric energy.

The energy transmitter can be adapted to generate an electromagneticfield, a magnetic field or an electrical field. The wireless energy maybe transmitted by the energy transmission device by at least onewireless signal. More specifically, the energy transmitter may beadapted to transmit the energy by at least one wireless energy signal,which may comprise an electromagnetic wave signal, including at leastone of an infrared light signal, a visible light signal, an ultra violetlight signal, a laser signal, a microwave signal, an X-ray radiationsignal, and a gamma radiation signal. Also, the wireless energy signalmay comprise a sound or ultrasound wave signal. Furthermore, thewireless energy signal may comprise a digital or analog signal or acombination thereof.

Galvanic Energy Transmission

Where energy is not transmitted wirelessly, galvanic coupling elementsshould be provided at least between the energy source and the motor fortransmitting energy to the motor in contacting fashion.

Control Unit

It is advantageous to provide a control unit adapted to directly orindirectly control one or more elements of the system, such as forcontrolling opening of the exit valve and/or closing of the entry valve,in particular in a manner such that when one of the two valves isclosed, the respective other valve is open, and vice versa. The controlunit can also be adapted to control actuation of the pump.

The control unit is preferably operable by the patient, e.g.particularly in order to empty the reservoir.

At least part of the control unit may be adapted to be implantable inthe patient's body. For instance, a manually operable switch may beprovided for activating the control unit, the switch preferably beingarranged for subcutaneous implantation so as to be operable from outsidethe patient's body. Also, the control unit may comprise a first partadapted for implantation in the patient's body and a second part adaptedto cooperate with the first part from outside the patient's body. Inthis case, the control unit can be adapted to transmit data from theexternal second part of the control unit to the Implanted first part ofthe control unit in the same manner as energy is transmitted to the atleast one energy consuming part.

That is, the second part of the control unit may be adapted towirelessly transmit a control signal to the implantable first part ofthe control unit for controlling the at least one energy consuming partfrom outside the patient's body. Also, the implantable first part of thecontrol unit may be programmable via the second part of the controlunit. Furthermore, the implantable first part of the control unit may beadapted to transmit a feedback signal to the second part of the controlunit

Sensor

Furthermore, a physical parameter sensor adapted to directly orindirectly sense a physical parameter of the patient can be provided.The physical parameter sensor may be adapted to sense at least one ofthe following physical parameters of the patient: a pressure within theartificial intestine section, a pressure within the patient's intestine,an expansion of the artificial intestine section, a distension of anintestinal wall of the patient's intestine, a movement of the intestinalwall.

Similarly, a functional parameter sensor adapted to directly orindirectly sense a functional parameter of the system can be provided,wherein the functional parameter sensor may be adapted to sense at leastone of the following functional parameters of the system: a pressureagainst a part of the system such as the artificial intestine section, adistension of a part of the system such as a wall of the artificialintestine section, an electrical parameter such as voltage, current orenergy balance, a position or movement of a movable part of the system.

Preferably, an indicator is coupled to the sensor or sensors, theindicator being adapted to provide a signal when a sensor senses a valuefor the parameter beyond a predetermined threshold value. The sensorsignal may comprise at least one of the following types of signals: asound signal, a visual signal.

Intestinal Contents Collecting Device (with “External” Pump)

Where the artificial intestine piece comprises a reservoir, in a simpleway, an intestinal contents collecting device may used to be temporarilyapplied from outside the patient's body when the reservoir is to beemptied. According to a preferred embodiment, the collecting device maycomprise a front open end adapted to be applied towards the exit valveso as to provide a flow passage from the exit valve towards thecollecting device. More specifically, the collecting device front openend is preferably adapted to be applied to the exit valve so as to openthe valve and thereby provide said flow passage towards the collectingdevice. Where the exit valve is normally closed by resilient means, saidfront open end is adapted to be inserted through the central opening ofthe exit valve so as to urge apart the resilient means normally closingthe central opening.

The collecting device preferably comprises a suction pump, which maycomprise a piston-cylinder-arrangement. The suction pump may be adaptedto be driven manually, in particular where it is intended for use as aback-up pump for a situation where the pump of the flow control deviceis out of operation. However, preferably a motor is connected to thesuction pump for driving the pump automatically.

Method of Treatment (Implantation)

The invention does not only relate to the artificial intestine sectionand systems described above, but also to a method of treating a patienthaving a disorder related to the patient's intestine.

Lateral Connection

Connecting at least the first open end portion of the artificialintestine section laterally to the patient's intestine involves thefollowing steps of a surgical method of treating a patient:

cutting the patient's skin and abdominal wall,

dissecting an area of the patient's intestine,

surgically creating at least one opening in a wall of the dissectedintestinal area so as to create an artificial lateral intestinalopening,

providing an artificial intestine section having a first open endportion and a second open end portion in flow communication with oneanother and affixing the first open end portion to the lateralintestinal opening so as to be in flow communication therewith, and

suturing the abdominal wall and skin.

A corresponding laparoscopic surgical method of treating a patient wouldcomprise the steps of:

making a small opening in the patient's skin and abdominal wall,

introducing a needle in the abdominal cavity,

inflating the abdominal cavity with gas,

inserting at least one trocar into the cavity,

introducing a camera through the trocar,

inserting at least one dissecting instrument preferably through a secondtrocar,

dissecting an area of the intestine,

surgically creating at least one opening in a wall of the dissectedintestinal area so as to create an artificial lateral intestinalopening,

providing an artificial intestine section having a first open endportion and a second open end portion in flow communication with oneanother and affixing the first open end portion to the lateralintestinal opening so as to be in flow communication therewith,

extracting the instruments, camera and trocar, and in relation thereto

suturing, if necessary, the abdominal wall and permanently closing theskin.

Closing the Intestine by Sewing

The dissected portion may be permanently closed at a location downstreamof the lateral intestinal opening so as to create an upstream part ofthe intestine including the lateral intestinal opening and a downstreampart of the intestine, and the second open end portion of the artificialintestine section may be affixed to the downstream intestinal part,preferably again to a lateral opening in the wall of the downstreamintestinal part. The downstream intestinal part may be connected to asurgically created stomy or to the patient's rectum or anus or to tissueadjacent the patient's anus. The step of permanently closing thepatient's intestine preferably comprises sewing and/or stapling theintestinal wall so as to form a dead end.

Dividing the Intestine

The patient's intestine may alternatively be divided and the artificialintestine piece may be placed between the resulting upstream anddownstream intestinal parts. This would require the following steps:

dissecting a portion of the dissected intestinal area downstream of thelateral intestinal opening such that intestinal mesentery connected tothe dissected portion is opened in such a way that supply of bloodthrough the mesentery to the dissected intestinal area is maintained asfar as possible on both sides of the dissected portion,

dividing the patient's intestine in the dissected portion so as tocreate an upstream part of the intestine with the lateral intestinalopening and a downstream part of the intestine, said downstreamintestine part being separate from the upstream intestine part andhaving a cross-sectional opening at the upstream side thereof, whereinthe mesentery maintains a tissue connection between the upstream anddownstream Intestine parts,

affixing the second open end portion of the artificial intestine sectionto the downstream intestine part, and

permanently closing the upstream intestine part at a location downstreamof the lateral intestinal opening.

Lateral Front and Lateral End Connection (By-Pass)

As mentioned before, preferably not only the first open end but also thesecond open end of the artificial intestine section are connected to alateral opening in the patient's intestinal walls. This would involvethe following steps to be performed on the downstream intestinal part:

surgically creating an opening in a wall of the downstream intestinalpart at an upstream end thereof so as to create a second artificiallateral intestinal opening, and

affixing the second open end portion of the artificial intestine sectionto the second lateral intestinal opening so as to be in flowcommunication therewith.

The step of permanently closing the patient's intestine may thencomprise sewing the intestinal wall with two rows of sutures or staplesand cutting and dividing the intestine between the sutures or staples soas to form two dead ends.

Alternatively, where the method of implanting the artificial intestinesection involves dividing the patient's intestine, the step of affixingthe second open end portion of the artificial intestine section to thedownstream intestinal part may comprise the steps of:

surgically creating an opening in a wall of the downstream intestinalpart at an upstream end thereof so as to create a second artificiallateral intestinal opening,

affixing the second open end portion of the artificial intestine sectionto the second lateral intestinal opening so as to be in flowcommunication therewith, and

permanently closing the cross-sectional opening at the upstream side ofthe downstream intestine part at a location upstream of the secondlateral intestinal opening, e.g. by sewing and/or stapling.

Lateral Front Connection and Straight End Connection

However, the second open end portion of the artificial intestine sectioncan likewise be affixed to a cross-sectional upstream opening of thedownstream intestinal part of the divided intestine so as to be in flowcommunication therewith.

Sleeve/Bulge Connector

The step of affixing the second open end portion of the artificialintestine section to a cross-sectional upstream opening of thedownstream intestine part preferably comprises:

inserting the second open end portion of the artificial intestinesection into the upstream opening of the downstream intestine part, and

placing a flexible sleeve so as to extend over both the downstreamintestine part and second open end portion of the artificial intestinesection such that the downstream intestine part is located intermediatethe sleeve and the outer surface of the artificial intestine section.

Where the flexible sleeve is mounted on the outer surface of the secondopen end portion of the artificial intestine piece so as to be foldableupon itself, the step of placing the flexible sleeve so as to extendover both the downstream intestine part and second open end portion ofthe artificial intestine section comprises folding the flexible sleeveupon itself such that the downstream intestine part is locatedintermediate the folded sleeve.

Alternatively, or in addition, the step of affixing the second open endportion of the artificial intestine section to the cross-sectionalupstream opening of the downstream intestine part may comprise:

inserting the artificial intestine section having a bulge formed on theoutside thereof into the upstream opening of the downstream intestinepart so that the downstream intestine part extends over the bulge fromone side of the bulge, and

advancing a blocking ring over the downstream intestine part towards thebulge from the respective other side of the bulge such that thedownstream intestine part is located intermediate the outer surface ofthe artificial intestine section and the blocking ring.

The afore-mentioned second open end portion of the artificial intestinesection with a sleeve or with a bulge serve to improve the strength ofthe connection against axial forces which may e.g. result from theperistaltic movement of the intestine and tend to pull on the intestine.The second open end portion of the artificial intestine section may alsocombine a sleeve and a bulge.

Exit Through Stoma

As mentioned before, the downstream intestinal part may be connected toa surgically created stomy or to the patient's rectum or anus or totissue adjacent the patient's anus. In the case of a connection to astomy, this would involve the following steps:

cutting the patient's skin and abdominal wall so as to create an openingfor an intestinal stomy,

dissecting the area of the stomy opening,

dividing the intestine at a location downstream of the artificialintestine piece so as to create an upstream natural intestine sectionhaving a cross-sectional opening at the downstream end thereof and adownstream natural intestine section,

dissecting the mesentery of the upstream natural intestine section inthe area of the cross-sectional opening thereof to prepare for creatingthe intestinal stomy,

advancing the downstream end of the upstream natural intestine sectionthrough the abdominal wall and skin, and

suturing the cross-sectional opening of the upstream natural intestinesection to the skin with the intestinal mucosa turned inside out,thereby achieving the intestinal stomy.

Exit Through Anus

In the case of a connection to the patient's anus or to tissue adjacentthe patient's anus, this would involve the following steps:

dividing the intestine at a location downstream of the artificialintestine piece so as to create an upstream natural intestine sectionhaving a cross-sectional opening at the downstream end thereof and adownstream natural intestine section leading to the patient's anus,

dissecting the area of the patient's anus and surgically separating thedownstream natural intestine section from the patient's anus, whereasthe steps of dividing the intestine and separating the intestine sectionleading to the patient's anus can alternatively be carried out inreversed order,

dissecting the mesentery of the upstream natural intestine section inthe area of the cross-sectional opening at the downstream end thereof toprepare for connecting the upstream natural intestine section to thepatient's anus or tissue adjacent the patient's anus,

advancing the downstream end of the upstream natural Intestine sectionthrough the patient's anus, and

suturing the cross-sectional opening of the upstream natural intestinesection to the patient's anus or tissue adjacent the patient's anus.

Depending upon the circumstances, the step of dividing the intestine soas to form the upstream natural intestine section may be performedeither on the patient's small intestine or on the patient's largeintestine.

Structure of Attachment

Where the first open end portion of the artificial intestine section andpossibly also the second open end portion are to be affixed to thelateral intestinal opening so as to be in flow communication therewith,this may comprise the step of connecting the afore-mentioned shoulderportion, which is formed around the open end portion, to the patient'sintestinal wall so as to surround the lateral intestinal opening. Inparticular, the step of affixing the open end portion to the intestinemay comprise attaching the shoulder portion to the patient's outerintestinal wall.

Alternatively, where the shoulder portion is split into an upper and alower shoulder portion with a gap between the upper and lower shoulderportions, the step of affixing the open end portion of the artificialintestine section to the lateral intestinal opening may comprise placingthe lower shoulder portion inside the patient's intestine and the uppershoulder portion outside the patient's intestine such that theintestinal wall tissue is accommodated in the gap.

The step of affixing the open end portion of the artificial intestinesection to the lateral intestinal opening may comprise gluing, sewingand/or stapling the open end portion to the patient's intestinal wall.

As a material for the first open end portion at least one biocompatiblematerial from the following group of materials may be selected:titanium, stainless steel, ceramics, biocompatible polymer material,wherein the biocompatible polymer is preferably selected from thefollowing group of polymers: polytetrafluoroethylene, silicone,polyurethane, expanded polytetrafluoroethylene (ePTFE).

More specifically, a multilayer material may be selected for the firstopen end, in particular one having a porous ingrowth layer allowingingrowth of living tissue. The ingrowth layer is preferably chosen tohave a net-like structure.

Intestinal Content Interacting Device within Artificial IntestinePiece/Reservoir/Flow Control Device

As mentioned before, the artificial intestine section or system maycomprise at least one element adapted to directly or indirectly interactwith intestinal contents contained in the artificial intestine sectionbetween the first and second open end portions thereof. This elementwill be implanted along with the artificial intestine section. As alsomentioned before, the element may comprise a reservoir for receiving andtemporarily collecting therein intestinal contents supplied through thefirst open end portion and/or a flow control device adapted to controlflow of intestinal contents from the artificial intestine sectionthrough the second open end portion.

Again, the flow control device may comprise an exit valve preventingintestinal contents flow through the second open end portion in itsclosed position and may additionally comprise an entry valve allowingintestinal contents to flow through the first open end portion into theartificial intestine section in its open position.

Alternatively or in addition, as also mentioned before, the flow controldevice may comprise a pump for advancing intestinal contents through thesecond open end portion to outside the artificial intestine section.Where the pump comprises a manually operable switch for activating thepump, the method of implantation may further comprise the step ofimplanting the switch subcutaneously so as to be operable from outsidethe patient's body.

Motor

Again, at least one motor may be implanted in the patient's body eitherseparately or, more preferably, integrally with the artificial intestinesection and may be arranged for automatically driving one or more energyconsuming part of the flow control device. Where the motor comprises amanually operable switch for activating the motor, the method ofimplantation may further comprise the step of implanting the switchsubcutaneously so as to be operable from outside the patient's body.

Energy Source/Energy Transmission

The method of Implantation may further comprise the step of implantinginside the patients body an energy source, possibly comprising energystorage means such as a battery or an accumulator as described before,for supplying at least one of the energy consuming parts with energy.

Where energy is transmitted wirelessly, for instance from outside thepatient's body to inside the patient's body either to an energyconsuming part and/or to the accumulator or from the accumulator to theenergy consuming part, it may further be necessary to implant an energytransforming device for transforming the wireless energy into electricenergy. Alternatively or in addition, galvanic coupling elements may beimplanted, e.g. for transmitting energy to the energy consuming part incontacting fashion from outside the patient's body and/or from theimplanted energy source.

Control Unit

Furthermore, as mentioned previously, at least a part of a control unitmay be implanted inside the patient's body adapted to directly orindirectly control one or more of the elements that have also beenimplanted in the patient's body. Where the control unit comprises amanually operable switch for activating the control unit, the method ofimplantation may further comprise the step of implanting said switchsubcutaneously so as to be operable from outside the patient's body.

Sensor

As mentioned before, one or more physical and/or functional parametersensors may be implanted to directly or indirectly sense physical and/orfunctional parameters inside the patient and in the system implantedinside the patient. Where the sensor is a pressure sensor, it may beplaced in the artificial intestine section or the patient's naturalintestine so as to sense the pressure within the artificial intestinesection or patient's natural intestine, respectively. Where the sensoris a tension sensor, it may be placed in contact with the artificialintestine section or the patient's intestine so as to sense an expansionof the artificial intestine section or patient's natural intestine,respectively. Where the sensor is a movement sensor, it may be placed incontact with the artificial intestine section or the patient's naturalintestine so as to sense movement of the artificial intestine section orpatient's natural intestine, respectively. The functional sensor may beadapted to measure at least one of the following functional parametersof the system: an electrical parameter such as voltage, current orenergy balance or a stimulation parameter in relation to the system.

Use

Once the artificial intestine section or system according to theinvention has been properly installed, the flow control device can beused for emptying the reservoir implanted in the patient

Accordingly, a method of treating a patient by means of the artificialintestine section which comprises at least one element adapted todirectly or indirectly interact with intestinal contents contained inthe artificial intestine section may comprise the step of actuating theat least one element so as to interact with the intestinal contentscontained in the artificial intestine section between the first andsecond open end portions thereof.

Exit and Entry Valve

Where the at least one element comprises an exit valve preventingintestinal contents flow from the artificial intestine section throughthe second open end portion in its closed position, the method mayfurther comprise the steps of opening the exit valve and then removingintestinal contents from the artificial intestine section. Furthermore,where the at least one element further comprises an entry valve allowingintestinal contents to flow through the first open end portion into theartificial intestine section in its open position, the method mayfurther comprise the step of closing the entry valve before removingintestinal contents from the artificial intestine section.

In particular, the method of use may comprise the step of inserting aconduit from outside the patient's body into the artificial intestinesection, thereby mechanically urging the exit valve to open.

Pump

Where the at least one element interacting with intestinal contentsinside the artificial intestine piece comprises a pump, the method ofuse may further comprise the step of advancing intestinal contents fromthe artificial intestine section through the second open end portionthereof to outside the artificial intestine section by means of thepump. The pump may be activated by manually operating a subcutaneouslyarranged actuator from outside the patient's body.

Alternatively, a flow passage may be provided to extend from theartificial intestine section to an external collecting device andintestinal contents may then be removed from the artificial intestinesection by means of a suction pump.

Motor

The suction pump is preferably driven by means of a motor.

Furthermore, where the at least one element interacting with intestinalcontents inside the artificial intestine piece comprises a motor, themethod of use may further comprise the step of driving at least the exitvalve between its closed and open positions and/or driving at least thepump by means of the motor. In either case, the motor is preferablyactivated by manually operating a subcutaneously arranged actuator fromoutside the patient's body.

Energy

As mentioned before, energy may be transmitted from outside thepatient's body to at least one implanted energy consuming part of thesystem, preferably in the form of wireless energy. This may involve thefollowing additional steps:

transforming the wirelessly transmitted energy into electric energy bymeans of an energy transforming device,

storing the transformed energy in an energy storage means, and

supplying the stored energy from the energy storage means to at leastone implanted energy consuming part of the system.

Again, energy may be transmitted wirelessly from the storage means tothe energy consuming part.

Preferably, at least part of the wirelessly transmitted energy istransformed into electric energy and used for the energy consuming partof the system, as said part of the wirelessly transmitted energy istransformed into the electric energy.

Control

Where a first part of a control unit for controlling at least one energyconsuming part of the system is implanted inside the patient's body, themethod of use may further comprise the step of using the external secondpart of the control unit to transmit data to the implanted first part ofthe control unit. Preferably, the data are transmitted to the implantedfirst part of the control unit in the same manner as energy istransmitted to the implanted energy consuming part. More particularly,the data are preferably transmitted wirelessly to the

For instance, the implanted first part of the control unit can beprogrammed via the external second part of the control unit.Furthermore, a feedback signal may be transmitted from the implantedfirst part of the control unit to the external second part of thecontrol unit.

Sensor

Where one or more of the afore-mentioned sensors are provided, themethod of use may comprise the step of sensing a physical parameter inthe patient's body and/or a functional parameter of the artificialintestine piece or system in the patient's body, such as one or more ofthe following parameters: a pressure within the artificial intestinesection, a pressure within the patient's natural intestine, an expansionof the artificial intestine section, a distension of an intestinal wallof the patient's natural intestine, a movement of the patient'sintestinal wall, a pressure against a part of the system such as theartificial Intestine section, a distension of a part of the system suchas a wall of the artificial intestine section, an electrical parametersuch as voltage, current or energy balance, a position or movement of amovable part of the system.

A signal, such as a sound signal or a visual signal, may be providedwhen a value for the physical parameter sensed is beyond a predeterminedthreshold value.

Intestinal Disorder

“Intestinal Pump”

Another object of the present invention is to provide a convenientapparatus for treating a patient having a disorder related to thepassageway of the patient's intestines.

Yet another object of the present invention is to provide methods fortreating a patient having a disorder related to the passageway of thepatient's intestines.

Accordingly, in accordance with a first aspect of the present invention,there is provided an intestinal disorder treatment apparatus fortreating a patient having a disorder related to the passageway of thepatient's intestines, comprising a pump for implantation in the patient,the pump being operable on at least one selected portion of theintestines to pump intestinal contents through the passageway of theintestines, wherein the pump includes a constriction device adapted toalternately constrict the selected portion to at least substantiallyreduce the volume of the passageway of the intestines along the selectedportion and release the selected portion to increase the volume of thepassageway of the intestines along the selected portion, such thatintestinal contents is displaced through the passageway of theintestines.

For a patient where the selected portion of the intestines ends at thepatient's anus, the pump is adapted to pump intestinal contents out fromthe patient's body through the anus. This solution differs from theprior art according to U.S. Pat. No. 6,752,754 discussed above, in thatthe pump of the present invention operates on the patient's intestine,i.e., the constriction device of the pump constricts the intestine todisplace intestinal contents therein.

For an ileostomy, a jejunostomy, a colostomy or a rectostomy patient,where the patient's intestines are surgically modified ending in astoma, the pump is adapted to pump intestinal contents out from thepatient's body through the stoma.

The apparatus of the invention may include an artificial intestinalpiece adapted to be surgically joined to the patient's intestines toform part of the passageway of the intestines and to form at least partof the selected portion of the intestines to be constricted by theconstriction device. The constriction device may operate only on theartificial intestinal piece to minimize the risk of injuring theintestines. When the pump is not in operation, the constriction devicecan firmly constrict the artificial intestinal piece to completely closethe passageway of the intestines. Alternatively, there may be providedat least one implantable releasable closure adapted to engage theartificial intestinal piece to close the passageway of the intestines,or at least partially constrict the selected portion, when the pump isnot in operation, and to release the selected portion to open thepassageway of the intestines when the pump is in operation.

The artificial intestinal piece may be integrated with the patient'sintestines between two ends thereof. Specifically, the artificialintestinal piece may be joined directly or indirectly to the patient'sanus, whereby the pump can pump intestinal contents out from thepatient's body through the anus. This solution differs from the priorart according to U.S. Pat. No. 6,752,754 discussed above, in that thepump of the present invention operates on the artificial intestinalpiece, i.e., the constriction device of the pump constricts theartificial intestinal piece to displace intestinal contents therein.Alternatively, the artificial intestinal piece may be adapted to end ina stoma, whereby the pump can to pump intestinal contents out from thepatient's body through the stoma.

To keep the pump fixed in a desired position in the patient's abdomen,an engagement device may be attached to the pump, the engagement devicebeing adapted to attach the pump to tissue related to the patient'sabdominal cavity, such as the abdominal wall.

To externally protect the intestines, an elastic protective tubing maybe provided to at least partially cover the selected portion of theintestines, so that the constriction device of the pump constricts boththe protective tubing and the selected portion.

An implantable support may be provided to support the selected portionof the intestines as the constriction device constricts the selectedportion. Alternatively, the constriction device may be adapted toconstrict the selected portion against a tissue or a bone of thepatient's body.

The apparatus further comprises a control device for controlling thepump to operate the constriction device to alternately constrict andrelease the selected portion, such that intestinal contents is movedthrough the passageway of the intestines. The control device is suitablyoperable by the patient and preferably includes a wireless remotecontrol.

Electric Stimulation of the Intestines

An electric stimulation device may be provided for electricallystimulating muscle or neural tissue of the selected portion of theintestines to cause at least partial contraction of the selectedportion. Using such a stimulation device as a complement to theconstriction device enables a particularly careful treatment of thepatient's intestines so that the risk of injuring the intestines overtime is minimized, as will be evident from the embodiments of theinvention described below.

The stimulation device may include at least one electrode adapted tostimulate muscle or neural tissue of the selected portion of theintestinal tissue with electric pulses. Preferably, the stimulationdevice includes a plurality of electrodes separate from or integratedwith the constriction device, wherein the electrodes form a series ofelectrodes along the selected portion of the intestines. The electricpulses may be positive and/or negative, preferably combined positive andnegative pulses. The desired stimulation effect is achieved by varyingdifferent pulse parameters, such as the pulse amplitude, the off timeperiod between successive pulses, the pulse duration and the pulserepetition frequency. A pulse amplitude of about 5 mA and a pulseduration of about 300 μs are suited for neural stimulation, whereas apulse amplitude of about 20 mA and a pulse duration of about 30 μs aresuited for muscular stimulation. The pulse repetition frequency suitablyis about 10 Hz.

The control device advantageously controls the stimulation device tovariably energize the electrodes along the selected portion, for examplein accordance with a preset scheme, to cause partial contractions of theselected portion that over time change their positions on the selectedportion, whereby parts of the intestines that currently are notstimulated can restore substantially normal blood circulation beforethey are stimulated again. A number or groups of the electrodes may beprogressively energized in a direction upstream or downstream of theintestines. Alternatively, the electrodes may be energized one at a timein sequence or groups of the electrodes may be sequentially energized,either randomly or in accordance with a predetermined pattern.

Pump Design

Embodiments of the present invention including different conceivabledesigns of the pump will be described as follows.

In accordance with a simple embodiment of the invention, theconstriction device of the pump includes a first constriction elementfor constricting and releasing the selected portion at an upstream endthereof, and a second constriction element for constricting andreleasing the selected portion between the upstream and downstream endsthereof. In this embodiment, the control device controls the first andsecond constriction elements to alternately constrict and release theselected portion independently of one another.

For the operation of the pump, the control device is adapted to:

control the upstream first constriction element to constrict theselected portion to close the passageway of the intestines at theupstream end of the selected portion, and

control the second constriction element to constrict the selectedportion between the upstream and downstream ends thereof to moveintestinal contents contained in the selected portion downstream in thepassageway of the intestines.

The control device is also adapted to:

control the first and second constriction elements to release theselected portion to allow intestinal contents in the passageway of theintestines upstream of the selected portion to enter the selectedportion.

When the pump is not in operation, the stimulation device describedabove is used for cooperation with any of the constriction elements toclose the passageway of the intestines. Thus, the first and secondconstriction elements are adapted to be maintained in a rest position,in which at least one of the constriction elements gently constricts theselected portion to at least substantially decrease the cross-sectionalarea of the passageway of the intestines, and the control devicecontrols the stimulation device to stimulate the selected portion wherethe constriction element constricts the selected portion to close thepassageway of the intestines. The phrase “gently constrict the selectedportion” is to be understood as constricting the portion of theintestines without substantially hampering the blood circulation inintestinal tissue. The rest position allows for sufficient bloodcirculation in the blood vessels of the selected portion of theintestines, such that the intestinal tissues of the selected portionmaintain their integrity following long exposure to the constrictionelement that constricts the selected portion.

The stimulation device may also be used for cooperation with any of theconstriction elements when the pump is in operation. In this case, thestimulation device includes at least one electrode. Preferably, thestimulation device includes a plurality of electrodes forming a seriesof electrodes along a surface of at least one of the constrictionelements of the constriction device, wherein the surface contacts theselected portion of the intestines. The electrodes stimulate muscle orneural tissue of the selected portion with electric pulses where one ofthe first constriction element and the second constriction elementconstricts the selected portion.

For the operation of the pump where the constriction elements and thestimulation device cooperate, the control device:

controls the upstream first constriction element to gently constrict theselected portion to at least substantially decrease the cross-sectionalarea of the passageway of the intestines at the upstream end of theselected portion,

controls the stimulation device to stimulate the selected portion wherethe first constriction element constricts the selected portion to causecontraction of the selected portion to close the passageway of theintestines at the upstream end of the selected portion, and

controls the second constriction element to constrict the selectedportion between the upstream and downstream ends thereof to moveintestinal contents contained in the selected portion downstream in thepassageway of the Intestines.

Optionally, the stimulation device may cooperate with the secondconstriction element by electrically stimulating the selected portionwhere the second constriction element constricts the selected portion toreduce the volume of the passageway of the intestines. Specifically, thecontrol device may control the stimulation device to successivelystimulate the selected portion where the second constriction elementconstricts the selected portion, such that the selected portionconstricted by the second constriction element is progressivelycontracted. As a result, the intestinal contents is displaced in thepassageway of the intestines in a peristaltic manner. Alternatively, theconstriction device may include only a single elongated constrictionelement, wherein the control device controls the stimulation device tosuccessively stimulate the selected portion where the constrictionelement constricts the selected portion, such that the selected portionconstricted by the constriction element is progressively contracted,whereby intestinal contents is displaced in the passageway of theintestines in a peristaltic manner.

In accordance with a more sophisticated embodiment of the invention, theconstriction device of the pump includes a first constriction elementfor constricting and releasing the selected portion at an upstream endthereof, a second constriction element for constricting and releasingthe selected portion at a downstream end thereof, and a thirdconstriction element for constricting and releasing the selected portionbetween the upstream and downstream ends thereof. In this embodiment,the control device controls the first, second and third constrictionelements to alternately constrict and release the selected portionindependently of one another.

For the operation of the pump, the control device is adapted to:

control the upstream first constriction element to constrict theselected portion to close the passageway of the intestines at theupstream end of the selected portion,

control the downstream second constriction element to release theselected portion, and

control the third constriction element to constrict the selected portionbetween the upstream and downstream ends thereof to move intestinalcontents contained in the selected portion downstream in the passagewayof the intestines.

The control device is also adapted to:

control the downstream second constriction element to constrict theselected portion to close the passageway of the intestines at thedownstream end of the selected portion,

control the upstream first constriction element to release the selectedportion, and

control the third constriction element to release the selected portionbetween the upstream and downstream ends thereof to allow intestinalcontents in the passageway of the intestines upstream of the selectedportion to enter the selected portion.

When the pump is not in operation, the stimulation device describedabove is used for cooperation with any of the constriction elements toclose the passageway of the intestines, as described above in connectionwith the simple embodiment of the invention. Thus, the first, second andthird constriction elements are adapted to be maintained in a restposition, in which at least one of the constriction elements gentlyconstricts the selected portion to at least substantially decrease thecross-sectional area of the passageway of the Intestines, and thecontrol device controls the stimulation device to stimulate the selectedportion where the constriction element constricts the selected portionto close the passageway of the intestines.

The stimulation device may also be used for cooperation with any of thefirst, second and third constriction elements when the pump is inoperation. In this case, the stimulation device includes a plurality ofelectrodes forming a series of electrodes along a surface of at leastone of the constriction elements of the constriction device, wherein thesurface contacts the selected portion of the intestines. The electrodesstimulate muscle or neural tissue of the selected portion with electricpulses where one of the first constriction element and the secondconstriction element constricts the selected portion, and/or where thethird constriction element constricts the selected portion.

For the operation of the pump where the constriction elements and thestimulation device cooperate, the control device:

controls the upstream first constriction element to gently constrict theselected portion to at least substantially decrease the cross-sectionalarea of the passageway of the intestines at the upstream end of theselected portion,

controls the stimulation device to electrically stimulate the selectedportion where the first constriction element constricts the selectedportion to cause contraction of the selected portion to close thepassageway of the intestines at the upstream end of the selectedportion,

controls the downstream second constriction element to release theselected portion, and

controls the third constriction element to constrict the selectedportion between the upstream and downstream ends thereof to moveintestinal contents contained in the selected portion downstream in thepassageway of the intestines.

Optionally, the stimulation device may cooperate with the thirdconstriction element by electrically stimulating the selected portionwhere the third constriction element constricts the selected portion toreduce the volume of the passageway of the intestines. Specifically, thecontrol device may control the stimulation device to successivelystimulate the selected portion where the third constriction elementconstricts the selected portion, such that the selected portionconstricted by the third constriction element is progressivelycontracted. As a result, intestinal contents is displaced in thepassageway of the intestines in a peristaltic manner.

Furthermore, the control device:

controls the downstream second constriction element to gently constrictthe selected portion to at least substantially decrease thecross-sectional area of the passageway of the intestines at thedownstream end of the selected portion,

controls the stimulation device to stimulate the selected portion wherethe second constriction element constricts the selected portion to causecontraction of the selected portion to close the passageway of theintestines at the downstream end of the selected portion,

controls the upstream first constriction element to release the selectedportion, and

controls the third constriction element to release the selected portionbetween the upstream and downstream ends thereof to allow intestinalcontents in the passageway of the intestines upstream of the selectedportion to enter the selected portion.

In accordance with another embodiment of the invention, which includesthe stimulation device, the constriction device includes a firstconstriction element for constricting and releasing the selected portionat an upstream end thereof, and a second constriction element forconstricting and releasing the selected portion at a downstream endthereof, wherein said control device controls said first and secondconstriction elements to alternately constrict and release the selectedportion independently of each other. In this embodiment, the stimulationdevice is adapted to electrically stimulate the selected portion betweenthe upstream and downstream ends thereof to cause contraction of theselected portion to reduce the volume of the passageway of theintestines.

For the operation of the pump, the control device:

controls the upstream first constriction element to constrict theselected portion to close the passageway of the intestines at theupstream end of the selected portion,

controls the downstream second constriction element to release theselected portion, and

controls the stimulation device to successively stimulate the selectedportion between the upstream and downstream ends thereof to causeprogressive contraction of the selected portion, so that intestinalcontents is displaced in the passageway of the intestines in aperistaltic manner.

Optionally, the control device may control the upstream firstconstriction element to gently constrict the selected portion to atleast substantially decrease the cross-sectional area of the passagewayof the intestines at the upstream end of the selected portion, andcontrol the stimulation device to stimulate the selected portion wherethe first constriction element constricts the selected portion to causecontraction of the selected portion to close the passageway of theintestines at the upstream end of the selected portion.

Furthermore, the control device:

controls the downstream second constriction element to constrict theselected portion to close the passageway of the intestines at thedownstream end of the selected portion,

controls the upstream first constriction element to release the selectedportion, and

controls the stimulation device to cease stimulating the selectedportion between the upstream and downstream ends thereof to allowintestinal contents in the passageway of the intestines upstream of theselected portion to enter the selected portion.

Optionally, the control device may control the downstream secondconstriction element to gently constrict the selected portion to atleast substantially decrease the cross-sectional area of the passagewayof the intestines at the downstream end of the selected portion, andcontrol the stimulation device to stimulate the selected portion wherethe second constriction element constricts the selected portion to causecontraction of the selected portion to close the passageway of theintestines at the downstream end of the selected portion.

In accordance with another embodiment of the invention, the constrictiondevice is adapted to constrict any portions of a series of selectedportions of the intestines to close the passageway of the intestines,and the control device controls the constriction device to successivelyconstrict the selected portions of the series of selected portions tomove intestinal contents downstream in the passageway of the intestinesin a peristaltic manner. Specifically, the constriction device includesa plurality of constriction elements, each of which is moveable alongthe intestines to successively constrict the selected portions of theseries of selected portions, wherein the control device controls theconstriction device to cyclically move the constriction elements oneafter the other along the selected portions of the series of selectedportions. (Alternatively, the constriction device may include only onesingle constriction element.) Preferably, the constriction deviceincludes a rotor carrying the constriction elements, and the controldevice controls the rotor to rotate, such that each constriction elementcyclically constricts the selected portions of the series of selectedportions. Each constriction element suitably includes a roller forrolling on the intestines to constrict the selected portions thereof.

Optionally, the stimulation device described above may be used forcooperation with the constriction device to successively constrict andcontract the selected portions of the series of selected portions. Thus,the constriction device constricts any portions of the series ofselected portions to at least substantially decrease the cross-sectionalarea of the passageway of the intestines and the stimulation deviceelectrically stimulates the selected portion constricted by theconstriction device to close the passageway of the intestines. Thecontrol device controls the constriction device to successivelyconstrict the selected portions of the series of selected portions tomove intestinal contents in the passageway of the intestines in aperistaltic manner, while controlling the stimulation device tosuccessively stimulate the selected portions to cause successivecontractions thereof in harmony with the successive constrictions of theselected portions performed by the constriction device. Specifically,the stimulation device includes one or more electrodes positioned on theconstriction elements of the constriction device and adapted tostimulate intestinal tissue with electric pulses. A plurality of suchelectrodes may be distributed along a surface in relation to eachconstriction element, wherein the surface contacts the intestines as theconstriction element constricts any one of the selected portions. Thecontrol device controls the constriction device to cyclically move theconstriction elements one after the other along the selected portions ofthe series of selected portions, while controlling the stimulationdevice to energize the electrodes.

In accordance with another embodiment of the invention, the constrictiondevice includes at least one elongated constriction element extendingalong the intestines, preferably two elongated elements extending alongthe intestines at opposite sides thereof. The control device controlsthe constriction device, such that the elongated constriction elementsco-operate with each other to progressively constrict the selectedportion to move intestinal contents in the passageway of the intestines.The elongated constriction elements comprise contact surfacesdimensioned for contacting a length of the selected portion of theintestines at opposite sides thereof.

The contact surfaces are suitably convex, wherein the control devicecontrols the constriction device, such that the convex contact surfacesof the constriction elements rolls on and progressively constricts theselected portion of the intestines. Each constriction element is adaptedto change between a constriction state, in which the convex surface iscapable of rolling along and constricting the selected portion of theintestines, and a release state, in which the convex surface is releasedfrom the selected portion of the intestines.

Optionally, the stimulation device described above may be used forcooperation with the elongated constriction elements. Thus, the controldevice may control the stimulation device to stimulate the selectedportion as the elongated constriction element progressively constrictsthe selected portion. The electrodes of the stimulation device aresuitably longitudinally distributed on a surface of the elongatedconstriction element that contacts the selected portion of theintestines, wherein the control device controls the stimulation deviceto energize the electrodes successively along the elongated constrictionelement to cause progressive contraction of the selected portion of theintestines.

In accordance with another embodiment of the invention, saidconstriction device is adapted to radially expand at least a section ofthe selected portion of the intestines to form an expanded chamber ofthe passageway of the intestines along the selected portion, and toaxially constrict the expanded section of the selected portion to atleast substantially reduce the volume of the chamber, such thatintestinal contents is displaced through the passageway of theintestines. In operation, the control device controls the constrictiondevice to axially constrict and release the expanded section of theselected portion, so that intestinal contents is displaced through thepassageway of the intestines. The constriction device is adjustablebetween a rest position, in which it does not expand the section of theselected portion, and an expansion position, in which it expands thesection of the selected portion. Suitably, the constriction device isprovided with a material that allows growth of fibrotic tissue forexternally joining the expansion device with the wall of the selectedportion of the intestines, whereby the expansion device pulls the wallof the selected portion radially outwardly, when it is in its expansionposition, to form the expanded section of the selected portion.

Optionally, the stimulation device described above may be used forelectrically stimulating the expanded section of the selected portion,when the constriction device is in its expansion position, to causeaxial contraction of the expanded section of the selected portion. Theelectrodes of the stimulation device suitably form at least one seriesof electrodes extending around the expanded section of the selectedportion of the intestines.

Separate Closure

In an embodiment of the invention, there is provided at least oneimplantable releasable closure adapted to engage the selected portion ofthe intestines to close the passageway of the intestines, or at leastpartially constrict the selected portion, when the pump is not inoperation, and to release the selected portion to open the passageway ofthe intestines when the pump is in operation. Preferably, the closure atleast partially constricts the selected portion to at leastsubstantially decrease the cross-sectional area of the passageway of theintestines, when the pump is not in operation, and the stimulationdevice described above is provided to electrically stimulate muscle orneural tissue of the intestines to cause contraction of the intestineswhere the closure constricts the intestines to completely close thepassageway of the intestines. The electrodes of the stimulation device,which are separate from or integrated with the closure, are suitablydistributed along a surface of the closure that contacts the intestines.The control device controls the closure and the stimulation device toco-operate, to allow for sufficient blood circulation in the bloodvessels of the constricted intestines, such that intestinal tissuesmaintain their integrity following long exposure to the closure, whenthe pump is not in operation. Where the pump includes an elongatedconstriction element provided with electrodes of the stimulation device,as described above, the control device may variably energize theelectrodes, in order to always allow for sufficient blood circulation inthe blood vessels of the constricted intestine, where the pump operates.

Closing the Passageway of the Patient's Intestines by the Pump

Instead of providing the separate closure described above, theconstriction device of the pump can be maintained in a rest position, inwhich it keeps the selected portion at least partially constricted, whenthe pump is not in operation. When the constriction device is in thisrest position, it constricts the selected portion no more than to allowfor sufficient blood circulation in the blood vessels of the constrictedintestines, such that intestinal tissues maintain their integrityfollowing long exposure to the constriction device. Furthermore, theconstriction device constricts the intestines to at least substantiallydecrease the cross-sectional area of the passageway of the intestines,when the constriction device is in the rest position, and thestimulation device described above is provided to electrically stimulatethe intestines where the constriction device constricts the intestines,to cause contraction of the intestines to completely close thepassageway of the intestines. Preferably, the control device controlsthe stimulation device, to variably energize the electrodes of thestimulation device along the selected portion, to cause partialcontractions of the selected portion that over time change theirpositions on the selected portion, whereby parts of the intestines thatcurrently are not stimulated can restore substantially normal bloodcirculation before they are stimulated again.

Artificial Intestinal Piece

In an embodiment of the invention, an artificial intestinal piece issurgically joined to the patient's intestines to form part of thepassageway of the intestines and to form at least part of the selectedportion of the intestines to be constricted by the constriction device.A significant advantage of this embodiment is that a constriction deviceof the various pump designs described above can be used for operatingonly on the artificial intestinal piece, not on the sensitiveintestines. When the pump is not in operation, the constriction devicecan constrict the artificial intestinal piece to completely close thepassageway of the intestines.

The artificial intestinal piece may be Integrated with the patient'sintestines between two ends thereof, for example, where a piece of therectum has been removed due to cancer. Alternatively, the artificialintestinal piece may be joined directly or indirectly to the patient'sanus.

Where the artificial intestinal piece is implanted in an ileostomy, ajejunostomy, a colostomy or a rectostomy patient, the constrictiondevice constricts the artificial intestinal piece in order to dischargeintestinal contents through a stoma located downstream of the artificialintestinal piece. Alternatively, the artificial intestinal piece may endat such a stoma.

Manually Operable Pump

A subcutaneously implantable actuator operatively connected to theconstriction device of the pump may be provided, wherein the actuator ismanually actuatable for operating the constriction device.

In an embodiment of the invention, the constriction device ishydraulically operable, and the actuator is hydraulically connected tothe hydraulically operable constriction device. The actuator preferablyincludes a manually compressible resilient reservoir for hydraulic fluidused for operating the constriction device.

Suitably, there is provided a reverse servo hydraulicallyinterconnecting the reservoir and the hydraulically operableconstriction device. The term “reverse servo” is to be understood as amechanism that transfers a strong force acting on a moving elementhaving a short stroke into a weak force acting on another moving elementhaving a long stroke; i.e., the reverse function of a normal servomechanism. Thus, minor changes in the amount of fluid in a smallerreservoir, which in this case can be hydraulically connected to theresilient reservoir of the actuator, could be transferred by the reverseservo into major changes in the amount of fluid in a larger reservoir,which in this case can be hydraulically connected to the constrictiondevice. The reverse servo is particularly suited for manual operationthereof.

The reservoir is hydraulically connected to the hydraulically operableconstriction device, such that when the reservoir is manually compressedthe constriction device constricts the selected portion between theupstream and downstream ends thereof to move intestinal contentscontained in the selected portion downstream in the passageway of theintestines. When the resilient reservoir is manually released andrestores its uncompressed shape, the constriction device releases theselected portion between the upstream and downstream ends thereof toallow intestinal contents in the passageway of the intestines upstreamof the selected portion to enter the selected portion.

The hydraulically operable constriction device includes a constrictionelement and a hydraulic bellows device that operates the constrictionelement to constrict the selected portion between the upstream anddownstream ends thereof, when the bellows device is expanded. Thecompressible resilient reservoir is hydraulically connected to thebellows device, such that the bellows device is expanded when thereservoir is manually compressed and retracted, when the reservoir ismanually released and restores its uncompressed shape. Thus, the bellowsdevice operates the constriction element to release the selected portionbetween the upstream and downstream ends, when the bellows device isretracted.

In a specific embodiment of the invention, the hydraulically operableconstriction device includes a first hydraulically operable sub-devicefor constricting and releasing the selected portion at an upstream endthereof, a second hydraulically operable sub-device for constricting andreleasing the selected portion at a downstream end thereof, and a thirdhydraulically operable sub-device for constricting and releasing theselected portion between the upstream and downstream ends thereof. Thereservoir is hydraulically connected to the first, second and thirdsub-devices, such that when the reservoir is manually compressed, theupstream first sub-device constricts the selected portion to close thepassageway of the intestines at the upstream end of the selectedportion, the downstream second sub-device releases the selected portion,and the third sub-device constricts the selected portion between theupstream and downstream ends thereof to move intestinal contentscontained in the selected portion downstream in the passageway of theintestines. When the resilient reservoir is manually released andrestores its uncompressed shape, the downstream second sub-deviceconstricts the selected portion to close the passageway of theintestines at the downstream end of the selected portion, the upstreamsecond sub-device releases the selected portion, and the thirdsub-device releases the selected portion between the upstream anddownstream ends thereof to allow intestinal contents in the passagewayof the intestines upstream of the selected portion to enter the selectedportion.

The first sub-device of the constriction device includes a firstconstriction element and a first hydraulic bellows device that operatesthe first constriction element to constrict the selected portion at theupstream end when the first bellows device is expanded, the secondsub-device of the constriction device comprises a second constrictionelement and a second hydraulic bellows device that operates the secondconstriction element to release the selected portion at the downstreamend when the second bellows device is expanded, and the third sub-deviceof the constriction device comprises a third constriction element and athird hydraulic bellows device that operates the third constrictionelement to constrict the selected portion between the upstream anddownstream ends when the third bellows device is expanded. Thecompressible resilient reservoir is hydraulically connected to thefirst, second and third bellows devices, such that the bellows devicesare expanded when the reservoir is manually compressed and retractedwhen the reservoir is manually released and restores its uncompressedshape. Thus, the first bellows device operates the first constrictionelement to release the selected portion at the upstream end when thefirst bellows device is retracted, the second bellows device operatesthe second constriction element to constrict the selected portion at thedownstream end when the second bellows device is retracted, and thethird bellows device operates the third constriction element to releasethe selected portion between the upstream and downstream ends when thethird bellows device is retracted.

Where applicable, the pumps of the embodiments disclosed in thisspecification may be manually operable by using hydraulic means asdescribed above.

Powered Pump

In an embodiment of the invention, the pump is powered. The controldevice may include a manually operable switch for starting and stoppingthe powered pump, wherein the switch is adapted for subcutaneousimplantation in the patient. Alternatively, the control device mayinclude a wireless remote control, suitably operated by the patientholding it, for controlling the pump, i.e., to start and stop.

A wireless energy transmitter may be provided for transmitting wirelessenergy from outside the patient's body into the patient's body forpowering the pump. The energy transmitter may transmit wireless energyfor directly powering the pump, as the wireless energy is beingtransmitted. Among many things, the wireless energy may compriseelectromagnetic energy, such as an electric, an electromagnetic or amagnetic field, or a combination thereof, or electromagnetic waves fordirect power of the pump. For example, where the pump includes anelectric pump, wireless energy in the form of a magnetic or anelectromagnetic field may be used for direct power of the electric pump.

Thus, the electric pump runs directly during transmission of thewireless energy. This may be achieved in two different ways: a) using anenergy-transforming device implanted in the patient to transform thewireless energy into energy of a different form, preferably electricenergy, and powering the pump with the transformed energy, or b) usingthe wirelessly transmitted energy to directly power the pump. Preferablywireless energy in the form of an electromagnetic or magnetic field isused to directly influence specific components of the pump to createkinetic energy. Such components may include coils integrated in thepump.

Alternatively, an accumulator, such as a capacitor or a rechargeablebattery, may be provided for storing the electric energy produced by theenergy-transforming device, wherein the control device controls theaccumulator to release energy for powering the pump. An implantablecharge meter for measuring the charge of the accumulator may be providedand the control device may produce an indication in response to thecharge meter.

Sensor

In an embodiment of the invention, an implantable sensor is provided fordirectly or indirectly sensing a physical parameter of the patient or afunctional parameter of the apparatus. Regarding the physical parameter,the control device may produce an indication, such as, a sound signal ordisplayed information in response to the sensor sensing a value of thephysical parameter exceeding a threshold value, when the pump is not inoperation. The physical parameter may be the volume of the intestinalcontents in the selected portion of the intestines, the distension ofthe intestinal wall, or the pressure in the selected portion of theintestines.

Regarding the functional parameter of the apparatus, the control devicemay produce an indication, such as an alarm, a sound signal or displayedinformation in response to the sensor sensing a value of the functionalparameter exceeding a threshold value, when the pump is in operation.

Communication

In any of the above embodiments of the invention, there may be providedan external data communicator intended to be outside the patient's body,and an internal data communicator implantable in the patient forcommunicating with the external communicator. The internal datacommunicator feeds data related to the patient back to the external datacommunicator, and/or the external data communicator feeds data to theinternal data communicator.

Methods of the Invention

In accordance with a second aspect of the present invention, there isprovided a method for treating a patient having a disorder related tothe passageway of the intestines. The method comprises the steps of:

constricting a selected portion of the patient's intestines to at leastsubstantially reduce the volume of the passageway of the intestinesalong the selected portion, so that intestinal contents is displacedthrough the passageway of the intestines in the downstream directionthereof,

releasing the selected portion to increase the volume of the passagewayof the intestines along the selected portion, so that intestinalcontents in the passageway of the intestines upstream of the selectedportion enters the selected portion, and

repeating steps (a) and (b) an optional number of times.

Where the selected portion of the intestines ends at the patient's anus,the method further comprises performing steps (a) and (b) to dischargeintestinal contents through the anus. Alternatively, the method furthercomprises surgically modifying the patient's intestines to end at astoma, and performing steps (a) and (b) to discharge intestinal contentsthrough the stoma.

The method steps (a) and (b) can be performed in accordance with severalalternatives, as will be described in the following.

Alternative 1. Step (a) is performed by initially constricting theselected portion partially to close the passageway of the intestines atan upstream end of the selected portion and then constricting the entireselected portion, and step (b) is performed by initially fully releasingthe selected portion except at a downstream end thereof and thenreleasing the selected portion at the downstream end.

Alternative 2. Step (a) is performed by:

partially constricting the selected portion to at least substantiallydecrease the cross-sectional area of the passageway of the intestines atan upstream end of the selected portion.

electrically stimulating muscle or neural tissue of the constrictedselected portion at the upstream end to cause contraction of theconstricted selected portion to close the passageway of the intestinesat the upstream end of the selected portion, and

then constricting the entire selected portion.

Step (b) is performed by initially fully releasing the selected portionexcept at a downstream end thereof and then releasing the selectedportion at the downstream end.

Alternative 3. Step (a) is performed by:

partially constricting the selected portion to at least substantiallydecrease the cross-sectional area of the passageway of the intestines atan upstream end of the selected portion,

electrically stimulating muscle or neural tissue of the constrictedselected portion at the upstream end to cause contraction of theconstricted selected portion to close the passageway of the intestinesat the upstream end of the selected portion,

at least partially constricting the entire selected portion, and

then successively stimulating the selected portion from the upstream endto a downstream end thereof to cause progressive contraction of theselected portion, so that intestinal contents is displaced in thepassageway of the intestines in a peristaltic manner.

Step (b) is performed by ceasing stimulating the selected portion andfully releasing the selected portion except at a downstream end thereof,and then releasing the selected portion at the downstream end.

Alternative 4. Step (a) is performed by:

partially constricting the selected portion to at least substantiallydecrease the cross-sectional area of the passageway of the intestinesalong the entire selected portion, and

successively stimulating the constricted portion from an upstream end toa downstream end thereof to cause progressive contraction of theselected portion, so that intestinal contents is displaced in thepassageway of the intestines in a peristaltic manner.

Alternative 5. Step (a) is performed by successively constrictingportions of a series of selected portions of the intestines so thatintestinal contents is displaced downstream in the passageway of theintestines in a peristaltic manner.

Alternative 6. Step (a) is performed by:

successively constricting portions of a series of selected portions ofthe intestines so that each constricted portion at least substantiallydecreases the cross-sectional area of the passageway of the intestines,and

electrically stimulating each constricted portion to cause contractionof the constricted intestinal portion to close the passageway of theintestines, whereby intestinal contents is displaced downstream in thepassageway of the intestines in a peristaltic manner.

Alternative 7. Step (a) is performed by progressively constricting theselected portion so that intestinal contents is displaced downstream inthe passageway of the intestines in a peristaltic manner.

Alternative 8. Step (a) is performed by:

electrically stimulating the selected portion to cause contractionthereof, and

progressively constricting the contracted selected portion so thatintestinal contents is displaced downstream in the passageway of theintestines in a peristaltic manner.

The present invention also provides another method for treating apatient having a disorder related to the passageway of the intestines.This method comprises the steps of:

providing a pump including a constriction device engaging a selectedportion of the intestines to constrict and release the selected portion,

controlling the pump to operate the constriction device to alternatelyconstrict the selected portion to at least substantially reduce thevolume of the passageway of the intestines along the selected portionand release the selected portion to increase the volume of thepassageway of the intestines along the selected portion, so thatintestinal contents is displaced through the passageway of theintestines.

This method further comprises providing at least one releasable closureengaging the patient's intestines, and using the closure to at leastsubstantially close the passageway of the intestines, when the pump isnot in operation, and to release the intestines, when the pump is inoperation. The closure may be used to constrict the intestines to closethe passageway of the intestines.

Alternatively, the closure may be used to constrict the intestines to atleast substantially decrease the cross-sectional area of the passagewayof the intestines, wherein the method further comprises electricallystimulating muscle or neural tissue of the intestines to causecontraction of the intestines where the closure constricts theintestines to close the passageway of the intestines. In this case, themethod suitably comprises coordinating the operation of the closure andthe electric stimulation of the Intestines, to allow for sufficientblood circulation in the blood vessels of the constricted intestines, sothat intestinal tissues maintain their integrity following long exposureto the closure, when the pump is not in operation.

The present invention also provides a method (I) for using an apparatusas described above to treat a patient having a disorder related to thepassageway of the intestines. This method (I) comprises the steps of:

providing an apparatus as described above,

inserting a needle like tube into the abdomen of the patients body,

supplying gas through the tube to fill the abdomen with gas, therebyexpanding the abdominal cavity,

placing at least two laparoscopical trocars in the patient's body,

inserting through one of the trocars a camera into the abdomen,

selecting a portion of the patient's intestines,

inserting a dissecting tool through one of the trocars and dissecting anarea of the selected portion,

placing the pump of the apparatus in the dissected area in operativeengagement with the selected portion of the intestines, and

using the pump to pump intestinal contents through the passageway of theintestines. The method (I) may further comprise cutting an openingthrough the patient's skin and abdominal wall and passing the patient'sintestine through the opening creating a stoma, and selecting theportion of the patient's intestines in the vicinity of the stoma,wherein the pump is used for discharging the intestinal contents throughthe stoma.

The present invention provides another method (II) for using anapparatus as described above to treat a patient having a disorderrelated to the passageway of the intestines. This method (II) comprisesthe steps of:

providing an apparatus as described above,

cutting an opening through the patient's skin and abdominal wall,

selecting a portion of the patient's intestines,

inserting a dissecting tool through the opening and dissecting an areaof the selected portion,

placing the pump of the apparatus in the dissected area in operativeengagement with the selected portion of the intestines, and

using the pump to pump intestinal contents through the passageway of theintestines.

The present invention provides yet another method (Ill) for using anapparatus as described above to treat a patient having a disorderrelated to the passageway of the intestines. This method (III) comprisesthe steps of:

cutting an opening through the patient's skin and abdominal wall andpassing a portion of the patient's intestines through the openingcreating a stoma,

cutting the intestines to separate a short piece of the intestinesforming the stoma from the remaining part of the intestines whilekeeping blood vessels of the mesentery connected to the short piece ofthe Intestines, to ensure blood supply to the short piece of theintestines,

dissecting an area at the short piece of the intestines,

placing an artificial intestinal piece in the dissected area, andsurgically joining it to the short piece of the intestines and to theremaining part of the intestines to form a continuous passageway of theintestines through the remaining part of the intestines, the artificialintestinal piece and the short piece of the intestines, the artificialintestinal piece forming a selected portion of the patient's intestines,

providing an apparatus as described above,

placing the pump of the apparatus in operative engagement with theartificial intestinal piece, and

using the pump to pump intestinal contents through the passageway of theintestines and out of the stoma.

The above methods (I), (II) and (III) may further comprisesubcutaneously implanting a manually operable switch for starting andstopping the pump.

In accordance with the above methods (I), (II) and (III), theconstriction device of the pump is put in operative engagement with theselected portion of the intestines, and the pump is controlled tooperate the constriction device to alternately constrict the selectedportion to at least substantially reduce the volume of the passageway ofthe intestines along the selected portion, and release the selectedportion to increase the volume of the passageway of the intestines alongthe selected portion, so that intestinal contents is displaced throughthe passageway of the intestines.

The methods (I), (II) and (III) further comprise implanting at least onereleasable closure in operative engagement with the selected portion ofthe intestines, and using the releasable closure to close the passagewayof the intestines when the pump is not in operation and to release theintestines when the pump is in operation.

The methods (I), (II) and (III) further comprise implanting anelectrically powered operation device, such as an electric motor, foroperating the releasable closure. Alternatively, the operation deviceincludes a hydraulic operation device.

The methods (I), (II) and (Ill) further comprise transmitting wirelessenergy for powering the operation device, and when desired to pumpintestinal contents through the passageway of the intestines, poweringthe operation device with the transmitted energy to operate the closureto release the selected portion of the intestines.

The methods (I), (II) and (III) further comprise implanting a source ofenergy in the patient, providing an external source of energy,controlling the external source of energy to release wireless energy,transforming the wireless energy into storable energy, non-invasivelycharging the implanted source of energy with the transformed energy, andcontrolling the implanted source of energy from outside the patient'sbody to release energy for use in connection with the operation of thepump and/or releasable closure. The patient's intestines may besurgically modified to end in a stoma, and when desired to dischargeintestinal contents out from the patient's body, the implanted source ofenergy is controlled to supply energy for operating the releasableclosure to temporarily release the selected portion of the intestinesand the pump is used to pump intestinal contents in the passageway ofthe intestines out from the body through the stoma. The wireless energymay be transformed into a storable energy, such as electric energy,different than the wireless energy, wherein the storable energy is usedfor operating the pump and/or releasable closure.

Alternatively, the methods (I), (II) and (III) further compriseproviding an external source of energy outside the patient's body,controlling the external source of energy from outside the patient'sbody to release wireless energy, and using the released wireless energyfor operating the pump and/or releasable closure. For example, theexternal source of energy may be controlled to release wireless energydirectly operating the pump and/or releasable closure. The externalsource of energy may be controlled to release non-magnetic wirelessenergy, wherein the released non-magnetic wireless energy is used foroperating the pump and/or releasable closure. Alternatively, theexternal source of energy may be controlled to release electromagneticwireless energy, wherein the released electromagnetic wireless energy isused for operating the pump and/or releasable closure.

The wireless energy may be transformed into electrical energy inside thepatient's body by an implanted energy-transforming device, wherein theelectrical energy is used in connection with the operation of the pumpand/or releasable closure. The electrical energy may be directly used inconnection with the operation of the pump and/or releasable closure. Forexample, the pump and/or releasable closure may be directly operatedwith the electrical energy, as the energy-transforming device transformsthe wireless energy into the electrical energy.

The methods (I), (II) and (III) further comprise controlling thereleasable closure to:

at least partially restrict the passageway of the intestines in theselected portion to prevent intestinal contents from passingtherethrough, or

release the intestines to allow intestinal contents to be pumpedtherethrough by using the pump.

Step (a) may be performed by controlling the releasable closure topartially restrict the passageway of the intestines in the selectedportion and electrically stimulating the selected portion of theintestines to cause contraction thereof to further restrict thepassageway of the intestines to prevent intestinal contents from passingtherethrough.

The present invention provides yet another method for using anapparatus, as described above, to treat a patient having a disorderrelated to the passageway of the intestines. This method comprises:

providing a wireless remote control adapted to control the pump fromoutside the patient's body, and

-   -   the wireless remote control by the patient to start the pump,        when the patient wants to defecate, and stop the pump when the        patient has finished defecating.        Intestinal Reservoir with Implantable Flow Control Device

According to the invention, a system is provided that acts on anintestinal reservoir, i.e. on a reservoir which is formed fromsurgically modified intestine that has been cut along a mutual contactline of laterally adjacent sections of a bent portion of intestine andconnected so that the resulting upper and lower halves of the intestineform an intestinal wall of the reservoir. The system comprises anartificial flow control device implantable in the patient's body andadapted to control flow of the intestinal contents from said reservoir.The flow control device comprises at least one pump adapted to act onsaid intestinal wall so as to reduce the reservoir's volume in order toempty the reservoir.

Since the reservoir is made from tissue of the intestine, it is notnecessary to connect any artificial piece to living tissue of thepatient's natural intestine. Rather is the pump adapted to act on theintestinal wall of the reservoir and can therefore be implanted withinthe patient's body preferably outside the reservoir. Due to the pumpbeing implanted, an external collecting device need not be attached,removed and cleaned when emptying of the reservoir is desired.

Three preferred basic principles of such pump will be describedhereinafter, a mechanical type pump, a hydraulic type pump and anelectrical stimulation type pump. These pumps can be combined tocooperate, if desired.

Integrated and Adjacent Location of Pump

According to a first preferred embodiment, components of the pump areadapted for implantation in surgically created folds of said intestinalwall of the reservoir. This is particularly advantageous in relation tothe electrical stimulation type pump, as will be described hereinafter.

According to a second preferred embodiment, components of the pump areadapted for implantation inside the patient's body adjacent thereservoir. This is preferable in relation to all three pump types.

In either case, the components of the pump will not come into contactwith intestinal contents. However, it is not entirely excluded that apump is used in context with the present invention that is adapted to beat least partly placed inside the intestinal reservoir.

Electrical Stimulation Type Pump

The electrical stimulation type pump comprises at least one electricalstimulation apparatus adapted to electrically stimulate a muscle orneural tissue of said intestinal wall so as to cause at least partialcontraction thereof. This is a very gender way of constricting thereservoir. The electrical stimulation apparatus is preferably adapted toapply electric pulses to the intestinal wall. For this purpose, theelectrical stimulation apparatus preferably comprises at least onelectrode adapted to generate the electric pulses.

It is particularly advantageous to make use of an electrical stimulationapparatus which is adapted to stimulate different portions of theintestinal wall over time. Thus, different parts of the reservoir can beconstricted by stimulation of different intestinal wall portions atdifferent times in any predetermined stimulation pattern. This way, thepump can be adapted to empty the intestinal reservoir by pumpingintestinal contents along a section of the reservoir by, over time,electrically stimulating different portions of said intestinal wall in adirection of natural intestinal contents flow.

For this purpose, the electrical stimulation type pump may comprise aplurality of electrodes preferably mounted on one or more holdingdevices. The holding devices may be in the form of a cable or may haveany other shape, however, preferably a longitudinal, stripe-like orrod-like or plate-like shape. A plurality of electrodes may be arrangedin one or more rows along the length of the holding devices. Thelongitudinal holding devices can then be arranged side by side withlittle or no distance, when implanted, so as to cover substantially theentire intestinal reservoir on one side, preferably on two opposingsides, of the reservoir. This structure and arrangement is particularlysuitable for advancing intestinal contents through the reservoir in acontrolled manner. For instance, beginning at one end of the reservoir,the “entry”, mutually adjacent portions of the intestinal wall and,thus, mutually adjacent sections of the intestinal reservoir can bestimulated consecutively along the length of the reservoir until therespective other end of the reservoir is reached, the “exit”, so thatthe entire reservoir is in a constricted state at the end of theemptying process. Alternatively, the mutually adjacent portions of theintestinal wall can be stimulated in a wave-like manner, i.e. thepreceding portion can relax once the next following portion has beenstimulated sufficiently. However, the electrodes on the holding devicesmay likewise be activated all at the same time, thereby simultaneouslyurging away intestinal contents from all areas of the reservoir. In thiscase it is particularly important for the system to comprise an entryvalve at the upstream end of the intestinal reservoir which has to beclosed to prevent back-flow when the electrical stimulation type pump isactivated.

The length of the holding devices should be sufficient to substantiallyspan the entire width of the intestinal reservoir, in order tofacilitate handling and reduce the number of parts. The perfect lengthdepends on the size of the intestinal reservoir, but is preferably morethan 5 cm and can be more than 8 cm or even more than 10 cm.

Handling of a plurality of holding devices can be improved when they areembedded in a flexible web, e.g. integrated within a biocompatible,non-degradable polymer film, such as a polytetrafluoroethylene film. Theflexibility of the web allows the holding devices to follow movements ofthe intestinal reservoir, in particular when sections thereof areconstricted individually due to selective electric stimulation.

Instead of embedding the longitudinal holding devices in a flexible web,they may be adapted for implantation in surgically created folds of theintestinal wall of the reservoir. The open side of the folds may beclosed by sewing, bonding and/or stapling the tissue of the intestinalwall together so as to form bags for the longitudinal holding devicescarrying the electrodes, preferably after the holding devices have beenput in place. The holding devices need not necessarily be longitudinalbut may have any other shape, whereby the folds or bags formed from theintestinal wall are suitably formed to accommodate them. The electrodesmay of course be directly invaginated in the intestinal wall one by oneor in groups without being carried on a common holding device.

Alternatively, instead of providing a plurality of longitudinal holdingdevices with electrodes, the electrical stimulation apparatus may beformed as an integral unit on at least one side of the reservoir. Thismakes handling and manufacture even easier. However, an integral unit isrelatively stiff, if not entirely rigid, which might be less comfortablefor the patient as compared to e.g. the afore mentioned flexible web.Preferably, the integral unit has a size sufficiently large to span anarea of 4.5 cm×6 cm, or larger.

Independent of whether the holding devices are thin flexible stripes orjust cables leading to the electrodes, or rod-like or plate-like,combined in a flexible web or provided in the form of a stiff or rigidintegral unit, they are preferably so adapted that they can be arrangedin two planes in order to accommodate the intestinal reservoir betweenthese two planes.

Electrical Stimulation Apparatus Combined with Constriction Device

Alternatively, or preferably in addition to the electrical stimulationtype pump, the pump may comprise a constriction type pump implanted inthe patient's body for at least partly constricting the intestinalreservoir mechanically or hydraulically by acting from outside on theintestinal wall. Similar to the above described electrical stimulationtype pump, the constriction type pump may be adapted to pump intestinalcontents along the reservoir by, over time, constricting differentsections of the reservoir consecutively or in a wave-like manner in adirection of natural intestinal contents flow. Where individualelectrodes of the electrical stimulation type pump, or electrodescarried on one or more holding devices, are combined with constrictiondevices of the constriction type pump, the electrodes and theconstriction devices preferably act on the same portions of theintestinal wall so as to pump the intestinal contents along thereservoir by, over time, electrically stimulating different portions ofsaid intestinal wall and simultaneously constricting respective sectionsof the reservoir in the direction of natural intestinal contents flow.It is advantageous when the constriction type pump in operationconstricts the intestinal reservoir only partly, in order not to damagethe intestinal tissue. Complete constriction and, thus, emptying of thereservoir may then be obtained by additionally stimulating theintestinal wall portions electrically in a manner as described before.

It should be noted that, due to the surgical modifications, theintestinal reservoir itself has lost its natural peristalticcapabilities. Therefore, according to a preferred embodiment, theelectrical stimulation type pump is adapted to pump intestinal contentsalong the reservoir in a direction of natural intestinal contents flowby, over time, stimulating different portions of the intestinal wall ina wave-like (peristaltic) manner when constriction of the reservoircaused by the constriction type pump is released. Thereby, the fillingof the intestinal reservoir with intestinal contents supplied to thereservoir is improved. This is even useful in cases where the electricalstimulation type pump is not combined with a constriction type pump orwith any other pump device. In either case, an exit valve should beprovided at the downstream end of the intestinal reservoir, which has tobe closed while the reservoir is filling up, to prevent that intestinalcontents may escape from the reservoir unintentionally.

From the foregoing it becomes clear that the constriction type pump isadapted to act on said intestinal wall from the outside of the reservoirso as to empty the reservoir by squeezing the reservoir. This can beachieved either hydraulically or mechanically, i.e. by means of ahydraulic type pump or a mechanic type pump.

Hydraulic Type Pump

According to a preferred embodiment, a hydraulic type pump comprises anelectrically driven hydraulic pump, a hydraulically acting member foracting on the intestinal wall of the intestinal reservoir from theoutside thereof, and an artificial reservoir, wherein the electricallydriven hydraulic pump is adapted to pump hydraulic fluid from theartificial reservoir to the hydraulically acting member. Thehydraulically acting member may be tube-like or bag-like to accommodatethe reservoir therein. This facilitates implantation and ensures properplacement of the hydraulically acting member relative to the intestinalreservoir over long time.

Preferably, the hydraulically acting member comprises a plurality ofhydraulic chambers, each chamber acting on a different section of theintestinal reservoir. By filling the chambers in a predeterminedsequence, emptying of the reservoir can be controlled.

In a relatively simple structure, each hydraulic chamber ishydraulically interconnected with two other hydraulic chambers, exceptthe first and last chambers which are hydraulically connected to onlyone other hydraulic chamber and to the artificial reservoir. Thus, fluidcan flow from the artificial reservoir sequentially through thehydraulic chambers and back into the artificial reservoir. Preferably,the hydraulic chambers are interconnected by holes acting as throttlesfor the fluid. This way, fluid will slowly through the chambers, therebyfilling the first chambers before the last chambers, so that intestinalcontents in the intestinal reservoir are slowly squeezed out of theintestinal reservoir.

However, more sophisticated structures may be used, e.g. involving oneor more actively controlled valves between interconnected chambersinstead of the passively acting throttles. Also, instead ofinterconnecting each hydraulic chamber with respective other two of thehydraulic chambers, one or all of the hydraulic chambers may be arrangedeither such that they are hydraulically isolated from the respectiveother chambers and connected only to the hydraulic pump via individualhydraulic control lines, or such that they can be hydraulically isolatedfrom the respective other chambers by individually controllingrespective valves within the hydraulic path.

The electrically driven hydraulic pump is preferably adapted to evacuatethe hydraulically acting member by applying negative pressure, once theintestinal reservoir has been emptied. New filling of the reservoir withintestinal contents is thereby facilitated.

Alternatively, instead of using negative pressure, one can also rely onpassive evacuation of the hydraulically acting member. That is, as theintestinal reservoir fills with intestinal contents again, the fluidwithin the hydraulically acting member surrounding the intestinalreservoir is automatically urged back into the reservoir. This processcan be advantageously supported by means of one or more valves betweenthe hydraulically acting member and the artificial reservoir, which,when in an appropriate operational position, allows fluid to passivelyflow from the hydraulically acting member back into the artificialreservoir when the reservoir fills with intestinal contents and which,when in an appropriate other position, prevents the fluid to flow fromthe hydraulically acting member back into the artificial reservoir whenthe intestinal reservoir is being emptied.

Mechanical Type Pump

According to another preferred embodiment, a mechanical type pumpcomprises at least one mechanically acting member for acting on theintestinal wall from the outside of the intestinal reservoir and anelectrical motor adapted to drive the mechanically acting member foremptying the intestinal reservoir.

A preferred structure for the mechanically acting member comprises atleast one roller adapted to be rolled over the intestinal reservoir foremptying the reservoir from the outside thereof. For instance, tworollers may act simultaneously on opposite outer surface sides of theintestinal reservoir so as to squeeze the reservoir. Alternatively, oneroller may act on one outer surface side of the intestinal reservoiragainst a counteracting plate arranged on an opposite side of thereservoir. For each roller, two tracks may be provided, one on eachlateral side of the intestinal reservoir, for guiding the roller orrollers when driven by the electrical motor. Thus, the length of therollers must be sufficient to bridge the width of the intestinalreservoir. Therefore, similar to the length of the holding devicesmentioned before, the rollers should have a length of about 10 cm ormore and the tracks should preferably also have a length of about 10 cmor more. Preferably, the tracks each have a bent end portion so arrangedthat it directs away from the reservoir, when implanted. When the rolleror rollers are positioned at the track's bent end portion, theintestinal reservoir is not constricted and, thus, intestinal contentscan freely enter the intestinal reservoir.

Valve as Part of the Flow Control Device

As mentioned earlier, in addition to the at least one pump, the flowcontrol device is advantageously provided further with one or morevalves for controlling flow to and/or from the reservoir. These valvesare preferably implanted inside the patient's body outside a section ofthe patient's intestine and may comprise at least one element adapted toact on the intestine section from the outside thereof so as to act onand, in particular, prevent intestinal contents flow through theintestine section. This valve arrangement is advantageous inasmuch itsinstallment does not require any surgery on the respective part of theintestine.

For instance, an exit valve should be provided downstream of theintestinal reservoir preventing intestinal contents to flow from thereservoir in its closed position. Preferably, the exit valve is anormally closed valve so that no energy is needed to keep the valveclosed during the system's inactive periods.

In addition, an entry valve may be provided allowing intestinal contentsto flow towards the intestinal reservoir in its open position. This canbe advantageous particularly during the emptying of the reservoir inorder to prevent back flow, i.e. when the entry valve is closed.Therefore, the entry valve is preferably a normally open valve.Accordingly, the exit valve and the entry valve are preferably adaptedto cooperate such that when one of the two valves is closed, therespective other valve is open, and vice versa.

Exit Valve

The exit valve may comprise a hydraulic or mechanical constrictiondevice for constricting the intestine section so as to keep theintestine section closed. For instance, a hydraulic constriction devicemay comprise a compartment with a variable volume adapted to open andclose the valve by changing the compartment's volume. The compartmentpreferably has at least one flexible wall defining an opening for theintestine section to pass through, the opening being adapted to closeupon increase of the compartment's volume.

Alternatively, or in addition to the hydraulic or mechanicalconstriction device, the exit valve may comprise at least one electricalstimulation device adapted to electrically stimulate muscle or neuraltissue of the intestine section so as to cause at least partialcontraction of the intestine section in order to prevent intestinalcontents flow through the intestine section. Similar to the stimulationdevices of the electrical stimulation type pump described before, thestimulation device of the exit valve may comprise at least one electrodeadapted to apply electric pulses to the intestine section. It isparticularly advantageous to make use of an electrical stimulationdevice which is adapted to stimulate different portions of the intestinesection over time. Thus, different portions of the intestine section canbe constricted by stimulation at different times in any predeterminedstimulation pattern, thereby giving the intestine portions currently notstimulated time to recover and, thus, improving the blood circulation inthe respective intestine section.

Furthermore, the electrical stimulation device can specifically beadapted to stimulate, over time, the different portions of the intestinesection in a wave like manner in a direction opposite to naturalintestinal contents flow. As a result, the valve counteracts the naturalintestinal contents flow, thereby improving the valve's closingfunction.

In particular, where the exit valve comprises a constriction device andan electrical stimulation device in combination, the stimulation deviceand the constriction device can act on the same intestine section inorder to keep the intestine section closed. In this case, theconstriction device is preferably adapted to only partly constrict theintestine section in the valve's normal (closed) condition, whereas thestimulation device is adapted to stimulate, over time, differentportions of the intestine section in a wave like manner in a directionopposite to natural intestinal contents flow so as to urge out-flowingintestinal contents back towards the intestinal reservoir. This is avery gentle way of preventing intestinal contents from exiting theintestinal reservoir.

In addition, the electrical stimulation device is preferably adaptedsuch that it can likewise be used to pump intestinal contents along theintestine section in a direction of natural intestinal contents flow by,over time, stimulating different portions of the intestine section in awave-like manner. Emptying of the intestinal reservoir can be supportedin this manner. During this process, the partial constriction of theintestine section caused by the valve's hydraulic or mechanicalconstriction device is released.

Entry Valve

The entry valve may be simpler in construction than the exit valve, asthe entry valve is preferably a normally open valve. Thus, there is onlylittle danger that the tissue of the intestine section could be damageddue to an unduly long time period of interrupted blood flow. Therefore,the entry valve to be implanted upstream from the reservoir in order tocontrol flow of intestinal contents into the reservoir may substantiallyconsist of a hydraulic or mechanical constriction device forconstricting said intestine section at the time when the intestinalreservoir is being emptied.

Motor

It was already mentioned before, that the pump may comprise a motor forautomatically driving the pump. The motor is preferably arranged to bedriven by electric or electromagnetic energy. The same or a differentmotor can be arranged for driving the valve or valves, respectively,between the closed and open positions. A motor in the sense of thepresent invention is a device that transforms energy other thanmechanical energy into mechanical energy.

Preferably, the motor comprises a servo drive. The effect of the servodrive is that a motor with relatively little power and, thus, arelatively small motor can be used, while the time needed to perform thework increases proportionally. However, since the time for emptying theintestinal reservoir is not very critical, this trade off can beaccepted.

A manually operable actuator, e.g. a switch, may be provided foractivating the pump or the at least one motor, respectively, fromoutside the patient's body. The switch is preferably arranged forsubcutaneous implantation so as to be easily operable from outside thepatient's body.

Energy Supply

An energy source may be provided for supplying energy directly orindirectly to at least one energy consuming part of the system, inparticular for driving the pump. Preferably, the energy source includesa battery or an accumulator, such as one or more of a rechargeablebattery and a capacitor, as an energy storage means. The energy storagemeans is advantageously adapted for being implanted inside the patient'sbody.

Energy is preferably transmitted wirelessly. Thus, where the energysource is provided for supplying energy directly or indirectly to atleast one energy consuming part of the system, the energy source maycomprise a wireless energy transmitter adapted to wirelessly transmitenergy from outside the patient's body to the at least one energyconsuming part. Alternatively, where the energy source includes abattery or an accumulator, in particular one which is implanted in thepatient's body, the energy source may comprise a wireless energytransmitter adapted to wirelessly transmit energy from outside thepatient's body to the energy storage means.

Control Unit

It is advantageous to provide a control unit adapted to directly orindirectly control one or more elements of the system, such as forcontrolling not only the actuation of the pump but also the opening ofthe exit valve and/or closing of the entry valve, in particular in amanner such that when one of the two valves is closed, the respectiveother valve is open, and vice versa. The control unit is preferablyoperable by the patient, e.g. particularly in order to empty thereservoir, such as by actuating the afore-mentioned subcutaneouslyimplantable switch.

Also, the control unit may comprise a first part adapted forimplantation in the patient's body and a second part adapted tocooperate with the first part from outside the patient's body. In thiscase, the control unit can be adapted to transmit data from the externalsecond part of the control unit to the implanted first part of thecontrol unit in the same manner as energy is transmitted to the at leastone energy consuming part.

According to one embodiment of the system, the pump could furthercomprise a mounting device adapted to be mounted to the peritoneum. Themounting device could be adapted to pass through the peritoneal wall andhold said intestinal section, comprising a flange intended for placementoutside the peritoneum. The mounting device could be adapted to holdsutures and staplers passing through the peritoneal wall, whenimplanted, to hold said artificial intestine section.

According to one embodiment of the system, the pump could furthercomprise a mounting device adapted to be mounted to the peritoneum. Themounting device could be adapted to pass through the peritoneal wall andhold said intestinal section, comprising a flange intended for placementoutside the peritoneum. The mounting device could be adapted to holdsutures and staplers passing through the peritoneal wall, whenimplanted, to hold said artificial intestine section.

Sleeve

It is therefore an object of the present invention to provide animplantable tissue connector for connecting tubular living tissue in apatient's body, which connection should be reliable over time and notseverely harm the living tissue.

It is a further object to propose different uses for such tissueconnector as well as methods for implanting the tissue connector in apatient's body.

Accordingly, the implantable tissue connector of the present inventioncomprises a conduit with at least a first and a second end and furtherhaving an outer surface on which may be mounted at least one flexiblesleeve axially extending around at least part of said conduit. Accordingto a first embodiment, the flexible sleeve is initially mounted on saidouter surface either folded or rolled upon itself. According to a secondembodiment, the flexible sleeve is initially mounted on said outersurface so as to be foldable upon itself. According to a third, moregeneral embodiment, the flexible sleeve is not initially mounted on theconduit but will be mounted thereon only at the time of implantation ofthe tissue connector in the patients body.

The first end of the conduit of the tissue connector is connected to atubular part of living tissue by inserting the first end of the conduitinto the tubular part of living tissue. Where, according to the firstembodiment, the flexible sleeve is mounted on the outer surface of theconduit folded or rolled upon itself, the flexible sleeve is unfolded orunrolled such that at least part of the living tissue extending over theconduit's outer surface is located intermediate the sleeve and the outersurface of the conduit. Where, according to the second embodiment, theflexible sleeve is mounted on the outer surface of the conduit so as tobe foldable upon itself, the flexible sleeve is folded upon itself suchthat at least part of the living tissue is located intermediate thefolded sleeve or intermediate the conduit's outer surface and thesleeve. Where, according to the third embodiment, the flexible sleeve isprovided separate from the conduit, the sleeve is advanced over theconduit and the respective portion of tubular tissue such that at leastpart of the living tissue is located intermediate the sleeve and theconduit's outer surface.

Either way, the tubular tissue is located somewhere between the conduitand the flexible sleeve and can be held in that position in variousmanners that will be described in the following and that can be appliedindividually as well as in combination.

The advantages achieved with the tissue connector according to thepresent invention comprise a good sealing of the living tissue betweenthe conduit and the flexible sleeve as well as good protection of theliving tissue by the flexible sleeve. This way, the connection can bemade reliable over time while also protecting the tissue against harm.

Where the flexible sleeve overlaps with the living tissue that has beendrawn over the first end of the conduit, it is desirable that theflexible sleeve will exert radial pressure upon the tissue. Inapplications where there is no movement to be expected, this may besufficient to hold the tissue connector in place. In other instances,where the movement of the tissue material is to be expected, such aswhen used as a bowel connector, the radial pressure will assist inholding the components in place until they are otherwise fixed againstone another. In any case, it is preferable to design the flexible sleevesuch that the radial pressure is minimal so as not to prohibit the bloodcirculation in the living tissue.

Furthermore, the conduit should be designed such that it is lessflexible than the flexible sleeve at least in a radial direction so asto provide support to the sleeve against radial forces, in particularagainst the sleeve's aforementioned radial pressure. This way, the openinternal cross section of the conduit will not be affected by the radialforces caused by the flexible sleeve.

Another particularly preferred way of reliably connecting the livingtissue to the tissue connector involves a flexible sleeve that comprisesa porous ingrowth layer allowing ingrowth of living tissue. This willnot only strengthen any connection between the tissue connector and thetissue but will also serve to further seal the connection against anyleakage.

The ingrowth layer should be made from a material that stimulates tissueingrowth. Preferably, the ingrowth layer has a netlike structure thatcan be penetrated by ingrowing tissue, thereby creating a durableconnection between the living tissue and the flexible sleeve. Of course,the ingrowth layer should be made from a biocompatible material, such asDacron®.

Another way of reliably fixing the living tissue to the tissue connectorconsists in suturing the flexible sleeve to the living tissue.Alternatively, the suturing may be performed through the flexible sleeveand an outer wall of the conduit including an interposed portion of theliving tissue. Thereby, the tissue is fixed to both the flexible sleeveand the conduit. Leakage through needle penetrations caused by thesuturing, if any, will automatically close over time by overgrowingtissue material.

It is also possible to perform the suturing through a portion of theliving tissue and the outer wall of the conduit before the flexiblesleeve is placed over the living tissue. This eliminates any problems ofleakage through the penetration holes caused by the suturing as thesleeve will cover and seal such penetration holes.

Preferably, the thread used for suturing is made from a material that isabsorbable by the patient's body. Typically, the thread will be absorbedby the body within about 6 weeks. At that time, however, the tissueingrowth will be sufficiently advanced to compensate for the loss ofstrength that was initially provided by the thread.

Instead or in addition to suturing the flexible sleeve to the conduit bymeans of a preferably absorbable thread, the sleeve may be fixedlyconnected to the conduit along an axially extending portion of thesleeve in any other appropriate way. For instance, the conduit and thesleeve may be bonded along at least part of said axially extendingportion of the sleeve. A primer may be applied on the conduits outersurface and/or the flexible sleeve to enhance bonding characteristics.

The flexible sleeve may comprise a multi-layer material. This isparticularly advantageous where the flexible sleeve comprises theaforementioned porous ingrowth layer. For instance, the porous ingrowthlayer might itself not be sufficiently stable to be safely handled andpulled over the tubular tissue and/or the porous ingrowth layer mightnot be able to exert the radial pressure onto the tissue. In either ofthese cases, it is advantageous to provide the flexible sleeve with asupport layer for supporting the porous ingrowth layer.

The support layer may be made e.g. from polyurethane or from expandedpolytetrafluoroethylene (ePTFE). ePTFE is particularly preferred as itcan be designed with pores sufficiently large in size so as to allow forthe necessary exchange of particles and/or elements between theunderlying tissue and the surrounding area of the patient's body.Furthermore, the support layer may give better protection to the tissuethan the ingrowth layer.

It is preferable when after implantation the support layer forms anouter layer of the flexible sleeve or, at least, that the ingrowth layerwill be located radial inward from the support layer. Thus, where theflexible sleeve is mounted on the outer surface of the conduit so as tobe foldable up on itself, the ingrowth layer will be located betweenportions of the support layer when the sleeve is folded upon itself.Alternatively, where the flexible sleeve is mounted on the outer surfaceof the conduit folded or rolled upon itself, the ingrowth layer will belocated radial inward from the support layer when the sleeve is unfoldedor unrolled.

In the regards of materials, both the conduit and the flexible sleeveshould preferably be made from biocompatible material. As far as thesleeve is concerned, it preferably comprises polymers, such aspolytetrafluoroethylene (PTFE), ePTFE, silicone and/or polyurethane.

As far as the conduit is concerned, the same and other biocompatiblepolymer materials can be used, including e.g. polyetheretherketone(PEEK). However, other materials, such as ceramics and metals, inparticular titanium and stainless steel, can be used as well and arepreferable for their strength.

The conduit can be substantially longer than the particular portion ofthe conduit to which the tubular tissue is connected. In that case, itis preferable that the flexible sleeve is located proximately to therespective end of the conduit so that the part of the tissue drawn overthe conduit is not excessively large. The larger the overlapping part ofthe tissue is, the larger may become problems of blood circulationwithin that part of the tissue.

The tissue connector may be intended for connecting with one another twodifferent ends of tubular living tissue. In this case, the conduit mayhave one flexible sleeve at each of the conduit's first and second ends.Again, the flexible sleeves are preferably located proximately to saidfirst and second ends.

In order to facilitate the step of inserting the end or ends of theconduit into the tubular living tissue, it is advantageous to taper thefree end portion of the conduit's end or ends towards the edge of saidfree end portion. Alternatively or in addition, the free end portion maybe provided with a rounded edge. The rounded edge will help to preventany damage to the living tissue when the tissue is pulled over the freeend of the conduit

According to another particularly preferred embodiment of the invention,there are provided special elements for preventing the tubular tissuefrom slipping off of the conduit. Again, these means can be combinedwith any of the aforementioned options of fixing the living tissue tothe tissue connector.

More particularly, according to this preferred embodiment, the tissueconnector comprises at least one bulge extending outwardly from theconduit's outer surface in a circumferential direction of the conduitabout at least part of the conduit's circumference. Furthermore, atleast one blocking ring is loosely fitted over the outer surface of theconduit with a clearance between the conduit's outer surface and theblocking ring for mounting living tissue within said clearance. Theblocking ring has an inner cross sectional diameter which is smallerthan or substantially identical to an outer cross sectional diameter ofthe at least one bulge so as to prevent the blocking ring from slippingover the bulge when living tissue is mounted within the clearance.

When the tissue connector is implanted in a human being or animal, theliving tissue will be pulled over the conduit's outer surface includingthe bulge. Then the blocking ring will be advanced from the other sideof the bulge over the living tissue towards the bulge such that at leastpart of the living tissue is located intermediate the conduits outersurface and the blocking ring. This has the effect that, when the tissuetends to slip off of the conduit, it will carry the blocking ringtowards and against the bulge. By this action, the living tissue will becompressed between the bulge and the blocking ring, thereby preventingany further slippage. This effect is self-enhancing with increasingslipping force. As the force tends to decrease again, the compressionforce will decrease accordingly so that blood circulation within theliving tissue will not be negatively affected longer than necessary.

The size of the clearance in a radial direction depends upon theintended use of the tissue connector, i.e. upon the thickness of thetubular living tissue to which the tissue connector is connected.Accordingly, the size may be at average between 0.1 to 0.4 mm, 0.4 to0.8 mm, 0.8 to 1.3 mm, 1.3 to 2 mm, 2 to 3 mm, 3 to 4 mm, 4 to 5 mm,over 5 mm. The clearance should be slightly smaller than the thicknessof the living tissue so as not to severely affect blood circulationwithin the living tissue but nevertheless ensure sufficient frictionalcontact.

While the cross-sectional diameter of the blocking ring shouldpreferably be smaller than the cross-sectional diameter of the bulge, itcan in some instances be identical or even somewhat larger than thisbecause the thickness of the living tissue, even in a compressed state,adds up to the cross-sectional diameter of the bulge so that alltogetherthe blocking ring is prevented from slipping over the bulge. Therefore,in case of particularly thick living tissue, the inner cross-sectionaldiameter of the blocking ring may be even somewhat larger than the outercross-sectional diameter of the bulge.

Of course, it is again preferable to make the blocking ring from abiocompatible material, in particular those materials mentioned abovethat are also suitable for the conduit.

Where the tissue connector is intended to connect two different ends oftubular living tissue material, it may have two of the aforementionedbulges, preferably located proximately to the respective ends of theconduit, with preferably at least two blocking rings locatedintermediate the two bulges. Of course, more than one blocking ringand/or more than one bulge may be provided for each end of the conduit.

As mentioned at the outset, the use of the tissue connector of thepresent invention is not limited to its application at the end of thehuman's large bowel. It can be advantageously used in many otherapplications.

For instance, the tissue connector may be fitted into a human'sesophagus. In this case, the conduit of the tissue connector should havean inner diameter of between 2 and 3.5 cm to provide for a snug fit. Theclearance between the conduit and the blocking ring should be in therange of 2.5 to 5 mm.

Where the tissue connector is connected to a human's trachea, the innerdiameter should be chosen between 1.5 and 2.5 cm, depending upon theposition where at the human's trachea it is to be connected, in order toprovide for a snug fit. The clearance between the conduit and theblocking ring should be in the range of 1 to 2 mm.

Where the tissue connector is fitted into a human stomach, the innerdiameter of the conduit can vary with enlarged boundaries. The clearancebetween the conduit and the blocking ring should be in the range of 3.5to 5 mm.

The tissue connector may also be fitted into a human's gall bladder orits connecting outlet channels. In that case, the conduit should have aninner diameter of between 0.5 and 1.3 cm. The clearance between theconduit and the blocking ring should be in the range of 0.5 to 1.5 mm.

In case that the tissue connector is fitted into a human's small bowel,the inner diameter of the conduit should be between 2 and 3 cm. Theclearance between the conduit and the blocking ring should be in therange of 3 to 4 mm.

In case of the human's large bowel, whose diameter is highlystretchable, the inner diameter of the conduit should be between 3 and5.5 cm to provide for a snug fit. The clearance between the conduit andthe blocking ring should be in the range of 2 to 3.5 mm.

The tissue connector may also be fitted into a human's urethra. In thiscase, the conduit should have an inner diameter of between 0.4 and 0.8cm. The clearance between the conduit and the blocking ring should be inthe range of 0.5 to 1.5 mm.

Also, the tissue connector may be fitted into an human's ureter, inwhich case the inner diameter of the conduit should be chosen between0.4 and 0.7 cm. The clearance between the conduit and the blocking ringshould be in the range of 2 to 4 mm.

The tissue connector may also be connected to the kidney. In order tosnuggly fit it into a human's pelvic part of the kidney, the innerdiameter of the conduit should be in the range of 1 and 5 cm, dependingupon the position where at the human's pelvic it is to be connected. Theclearance between the conduit and the blocking ring should be in therange of 0.5 to 1.5 mm.

The tissue connector may also be fitted into a human's blood vessel. Inthis case, the inner diameter of the conduit should be chosenapproximately similar to the inner diameter of the respective bloodvessel. As an example, the inner diameter may be chosen between 0.1 and0.5 cm in the case of particularly small blood vessels. The tissueconnector may as well be connected to the human's aorta or the heart'satrium or ventricle, in which case the inner diameter of the conduit isin the range of 2 to 3 cm. The clearance between the conduit and theblocking ring should be in the range of 1 to 2 mm.

The tissue connector may also be used as an intermediate piece toreplace a part of tubular living tissue and may as well be used toconnect different types of tubular living tissue, such as where abiological transplant of a third party's body is to be connected to theorgans of a patient.

The tissue connector may particularly be used and be adapted forconnecting it to at last one of an implantable reservoir, an implantablepump, an implantable motor, an implantable medical device and abiological transplant. The artificial items may even form a part of thetissue connector, either integrally formed therewith or separatelyconnected thereto. The reservoir, pump, motor and/or medical device mayalso be incorporated in the tissue connector between the first andsecond ends of the conduit.

The biological transplant may be any transplant, such as a transplantedheart to be connected by means of the tissue connector to the patient'saorta and/or to other blood vessels (pulmonary arteria etc.).

Instead of being artificial, the aforementioned reservoir may consist ofa biological transplant, but it may as well be made from tissue materialof the patient into whom the reservoir is to be implanted. For instance,the reservoir may be a fecal excrements collecting container, such as aurine bladder or an intestine.

The reservoir may also be a reservoir for medical drugs for thepatient's needs and is preferably adapted to be filled with at least onemedical drug. Such medical drug reservoir may or may not be connected toa medical device, such as an implantable drug delivery device, whichmedical device may additionally include a pump for pumping the drug fromthe reservoir into the patient's body and possibly a motor for the pump.

Any other implantable medical devices may also be connected to theorgans of the patient by means of the tissue connector, with or withouta pump, motor and/or reservoir. Examples of these are an artificialheart, a penile prothesis, an artificial urine bladder, an artificialurethra, an artificial esophagus, an artificial trachea and the like.Examples of biological transplants include a urine bladder, anintestine, a urethra, a ureter, a kidney, a bowel, a heart, anesophagus, a trachea, a blood vessel and the like.

The tissue connector of the present invention can be implanted in ahuman being or animal either in open surgery or by subcutaneous surgery.In either case, the skin will have to be cut before free-dissecting anappropriate location within the patient's body adjacent to the tubularliving tissue and, after the conduit of the tissue connector has beenconnected with one or both ends to the tubular tissue, at least the skinwill have to be sutured at the end of the surgery.

Where the tissue connector is implanted by subcutaneous surgery, thesteps of cutting the skin and free-dissecting the appropriate locationwithin the patient's body comprise the steps of

-   -   a needle-like tube into the patient's body, such as the        patient's thorax or abdomen,    -   filling through said needle gas into the patient's body, i.e.        into the thorax cavity or abdomen cavity,    -   a key-hole,    -   at least one, preferably two, laparoscopic trocars through the        key-hole towards said location,    -   advancing one or more medical instruments and a camera through        the at least one trocar towards said location, i.e. into the        thorax or abdomen, and    -   dissecting an area of the tubular part of living tissue with the        aid of the dissecting tool.    -   The tissue connector may be supplied to said location through        the at least one trocar or through a separate incision.        Bulge

It is therefore an object of the present invention to provide animplantable tissue connector for connecting tubular living tissue in apatients body, which connection should be reliable over time and notseverely harm the living tissue.

It is a further object to propose different uses for such tissueconnector as well as methods for implanting the tissue connector in apatient's body.

Accordingly, the implantable tissue connector of the present inventioncomprises a conduit with at least a first and a second end and furtherhaving an outer surface.

According to the invention, there are provided special elements forpreventing the tubular tissue from slipping off of the conduit. Moreparticularly, the tissue connector comprises at least one bulgeextending outwardly from the conduit's outer surface in acircumferential direction of the conduit about at least part of theconduit's circumference. Furthermore, at least one blocking ring isloosely fitted over the outer surface of the conduit with a clearancebetween the conduit's outer surface and the blocking ring for mountingliving tissue within said clearance. The blocking ring has an innercross sectional diameter which is smaller than or substantiallyidentical to an outer cross sectional diameter of the at least one bulgeso as to prevent the blocking ring from slipping over the bulge whenliving tissue is mounted within the clearance.

When the tissue connector is implanted in a human being or animal, theliving tissue will be pulled over the conduit's outer surface includingthe bulge. Then the blocking ring will be advanced from the other sideof the bulge over the living tissue towards the bulge such that at leastpart of the living tissue is located intermediate the conduit's outersurface and the blocking ring. This has the effect that, when the tissuetends to slip off of the conduit, it will carry the blocking ringtowards and against the bulge. By this action, the living tissue will becompressed between the bulge and the blocking ring, thereby preventingany further slippage. This effect is self-enhancing with increasingslipping force. As the force tends to decrease again, the compressionforce will decrease accordingly so that blood circulation within theliving tissue will not be negatively affected longer than necessary.Thus, the connection will be reliable over time and not severely harmthe living tissue.

The size of the clearance in a radial direction depends upon theintended use of the tissue connector, i.e. upon the thickness of thetubular living tissue to which the tissue connector is connected.Accordingly, the size may be at average between 0.1 to 0.4 mm, 0.4 to0.8 mm, 0.8 to 1.3 mm, 1.3 to 2 mm, 2 to 3 mm, 3 to 4 mm, 4 to 5 mm,over 5 mm. The clearance should be slightly smaller than the thicknessof the living tissue so as not to severely affect blood circulationwithin the living tissue but nevertheless ensure sufficient frictionalcontact.

While the cross-sectional diameter of the blocking ring shouldpreferably be smaller than the cross-sectional diameter of the bulge, itcan in some instances be identical or even somewhat larger than thisbecause the thickness of the living tissue, even in a compressed state,adds up to the cross-sectional diameter of the bulge so that alltogetherthe blocking ring is prevented from slipping over the bulge. Therefore,in case of particularly thick living tissue, the inner cross-sectionaldiameter of the blocking ring may be even somewhat larger than the outercross-sectional diameter of the bulge.

In the regards of materials, both the conduit and the blocking ringshould preferably be made from biocompatible material. This preferablycomprises polymers, such as polytetrafluoroethylene (PTFE), ePTFE,silicone, polyurethane and/or polyetheretherketone (PEEK). However,other materials, such as ceramics and metals, in particular titanium andstainless steel, can be used as well and are preferable for theirstrength.

The conduit can be substantially longer than the particular portion ofthe conduit to which the tubular tissue is connected. In that case, itis preferable that the bulge is located proximately to the respectiveend of the conduit so that the part of the tissue drawn over the conduitis not excessively large. The larger the overlapping part of the tissueis, the larger may become problems of blood circulation within that partof the tissue.

Where the tissue connector is intended to connect two different ends oftubular living tissue material, it may have two of the aforementionedbulges, preferably located proximately to the respective ends of theconduit, with at least one and preferably at least two blocking ringslocated intermediate the two bulges. Of course, more than one blockingring and/or more than one bulge may be provided for each end of theconduit.

In order to facilitate the step of inserting the end or ends of theconduit into the tubular living tissue, it is advantageous to taper thefree end portion of the conduit's end or ends towards the edge of saidfree end portion. Alternatively or in addition, the free end portion maybe provided with a rounded edge. The rounded edge will help to preventany damage to the living tissue when the tissue is pulled over the freeend of the conduit

As mentioned at the outset, the use of the tissue connector of thepresent invention is not limited to its application at the end of thehuman's large bowel. It can be advantageously used in many otherapplications.

For instance, the tissue connector may be fitted into a human'sesophagus. In this case, the conduit of the tissue connector should havean inner diameter of between 2 and 3.5 cm to provide for a snug fit. Theclearance between the conduit and the blocking ring should be in therange of 2.5 to 5 mm.

Where the tissue connector is connected to a human's trachea, the innerdiameter should be chosen between 1.5 and 2.5 cm, depending upon theposition where at the human's trachea it is to be connected, in order toprovide for a snug fit. The clearance between the conduit and theblocking ring should be in the range of 1 to 2 mm.

Where the tissue connector is fitted into a human stomach, the innerdiameter of the conduit can vary with enlarged boundaries. The clearancebetween the conduit and the blocking ring should be in the range of 3.5to 5 mm.

The tissue connector may also be fitted into a human's gall bladder orits connecting outlet channels. In that case, the conduit should have aninner diameter of between 0.5 and 1.3 cm. The clearance between theconduit and the blocking ring should be in the range of 0.5 to 1.5 mm.

In case that the tissue connector is fitted into a human's small bowel,the inner diameter of the conduit should be between 2 and 3 cm. Theclearance between the conduit and the blocking ring should be in therange of 3 to 4 mm.

In case of the human's large bowel, whose diameter is highlystretchable, the inner diameter of the conduit should be between 3 and5.5 cm to provide for a snug fit. The clearance between the conduit andthe blocking ring should be in the range of 2 to 3.5 mm.

The tissue connector may also be fitted into a human's urethra. In thiscase, the conduit should have an inner diameter of between 0.4 and 0.8cm. The clearance between the conduit and the blocking ring should be inthe range of 0.5 to 1.5 mm.

Also, the tissue connector may be fitted into an human's ureter, inwhich case the inner diameter of the conduit should be chosen between0.4 and 0.7 cm. The clearance between the conduit and the blocking ringshould be in the range of 2 to 4 mm.

The tissue connector may also be connected to the kidney. In order tosnuggly fit it into a human's pelvic part of the kidney, the innerdiameter of the conduit should be in the range of 1 and 5 cm, dependingupon the position where at the human's pelvic it is to be connected. Theclearance between the conduit and the blocking ring should be in therange of 0.5 to 1.5 mm.

The tissue connector may also be fitted into a human's blood vessel. Inthis case, the inner diameter of the conduit should be chosenapproximately similar to the inner diameter of the respective bloodvessel. As an example, the inner diameter may be chosen between 0.1 and0.5 cm in the case of particularly small blood vessels. The tissueconnector may as well be connected to the human's aorta or the heart'satrium or ventricle, in which case the inner diameter of the conduit isin the range of 2 to 3 cm. The clearance between the conduit and theblocking ring should be in the range of 1 to 2 mm.

The tissue connector may also be used as an intermediate piece toreplace a part of tubular living tissue and may as well be used toconnect different types of tubular living tissue, such as where abiological transplant of a third party's body is to be connected to theorgans of a patient.

According to a preferred embodiment of the invention, at least oneflexible sleeve may be mounted on the outer surface of the conduit suchthat it axially extends around at least part of said conduit. Accordingto a first embodiment, the flexible sleeve is initially mounted on saidouter surface either folded or rolled upon itself. According to a secondembodiment, the flexible sleeve is initially mounted on said outersurface so as to be foldable upon itself. According to a third, moregeneral embodiment, the flexible sleeve is not initially mounted on theconduit but will be mounted thereon only at the time of implantation ofthe tissue connector in the patient's body.

The first end of the conduit of the tissue connector is connected to atubular part of living tissue by inserting the first end of the conduitincluding the bulge into the tubular part of living tissue. Where,according to the first embodiment, the flexible sleeve is mounted on theouter surface of the conduit folded or rolled upon itself, the flexiblesleeve is unfolded or unrolled such that at least part of the livingtissue extending over the conduit's outer surface is locatedintermediate the sleeve and the outer surface of the conduit. Where,according to the second embodiment, the flexible sleeve is mounted onthe outer surface of the conduit so as to be foldable upon itself, theflexible sleeve is folded upon itself such that at least part of theliving tissue is located intermediate the folded sleeve or intermediatethe conduit's outer surface and the sleeve. Where, according to thethird embodiment, the flexible sleeve is provided separate from theconduit, the sleeve is advanced over the conduit and the respectiveportion of tubular tissue such that at least part of the living tissueis located intermediate the sleeve and the conduit's outer surface. Ineither of the aforementioned three embodiments, the flexible sleeve mayor may not extend over the bulge.

Either way, the tubular tissue is located somewhere between the conduitand the flexible sleeve and can be held in that position in variousmanners that will be described in the following and that can be appliedindividually as well as in combination.

The advantages achieved with the tissue connector according to theaforementioned three preferred embodiments comprise a good sealing ofthe living tissue between the conduit and the flexible sleeve as well asgood protection of the living tissue by the flexible sleeve. This way,the connection can be made reliable over time while also protecting thetissue against harm.

Where the flexible sleeve overlaps with the living tissue that has beendrawn over the first end of the conduit, it is desirable that theflexible sleeve will exert radial pressure upon the tissue. In instanceswhere strong and/or repeated movement of the tissue material is to beexpected, such as when used as a bowel connector, the radial pressurewill assist in holding the components in place until they are otherwisefixed against one another. In any case, it is preferable to design theflexible sleeve such that the radial pressure is minimal so as not toprohibit the blood circulation in the living tissue.

Furthermore, the conduit should be designed such that it is lessflexible than the flexible sleeve at least in a radial direction so asto provide support to the sleeve against radial forces, in particularagainst the sleeve's aforementioned radial pressure. This way, the openinternal cross section of the conduit will not be affected by the radialforces caused by the flexible sleeve.

Another particularly preferred way of reliably connecting the livingtissue to the tissue connector involves a flexible sleeve that comprisesa porous ingrowth layer allowing ingrowth of living tissue. This willnot only strengthen any connection between the tissue connector and thetissue but will also serve to further seal the connection against anyleakage.

The ingrowth layer should be made from a material that stimulates tissueingrowth. Preferably, the ingrowth layer has a netlike structure thatcan be penetrated by ingrowing tissue, thereby creating a durableconnection between the living tissue and the flexible sleeve. Of course,the ingrowth layer should be made from a biocompatible material, such asDacron®.

Another way of reliably fixing the living tissue to the tissue connectorconsists in suturing the flexible sleeve to the living tissue.Alternatively, the suturing may be performed through the flexible sleeveand an outer wall of the conduit including an interposed portion of theliving tissue. Thereby, the tissue is fixed to both the flexible sleeveand the conduit. Leakage through needle penetrations caused by thesuturing, if any, will automatically close over time by overgrowingtissue material.

It is also possible to perform the suturing through a portion of theliving tissue and the outer wall of the conduit before the flexiblesleeve is placed over the living tissue. This eliminates any problems ofleakage through the penetration holes caused by the suturing as thesleeve will cover and seal such penetration holes.

Preferably, the thread used for suturing is made from a material that isabsorbable by the patient's body. Typically, the thread will be absorbedby the body within about 6 weeks. At that time, however, the tissueingrowth will be sufficiently advanced to compensate for the loss ofstrength that was initially provided by the thread.

Instead or in addition to suturing the flexible sleeve to the conduit bymeans of a preferably absorbable thread, the sleeve may be fixedlyconnected to the conduit along an axially extending portion of thesleeve in any other appropriate way. For instance, the conduit and thesleeve may be bonded along at least part of said axially extendingportion of the sleeve. A primer may be applied on the conduits outersurface and/or the flexible sleeve to enhance bonding characteristics.

The flexible sleeve may comprise a multi-layer material. This isparticularly advantageous where the flexible sleeve comprises theaforementioned porous ingrowth layer. For instance, the porous ingrowthlayer might itself not be sufficiently stable to be safely handled andpulled over the tubular tissue and/or the porous ingrowth layer mightnot be able to exert the radial pressure onto the tissue. In either ofthese cases, it is advantageous to provide the flexible sleeve with asupport layer for supporting the porous ingrowth layer.

The support layer may be made e.g. from polyurethane or from expandedpolytetrafluoroethylene (ePTFE). ePTFE is particularly preferred as itcan be designed with pores sufficiently large in size so as to allow forthe necessary exchange of particles and/or elements between theunderlying tissue and the surrounding area of the patient's body.Furthermore, the support layer may give better protection to the tissuethan the ingrowth layer.

It is preferable when after implantation the support layer forms anouter layer of the flexible sleeve or, at least, that the ingrowth layerwill be located radial inward from the support layer. Thus, where theflexible sleeve is mounted on the outer surface of the conduit so as tobe foldable up on itself, the ingrowth layer will be located betweenportions of the support layer when the sleeve is folded upon itself.Alternatively, where the flexible sleeve is mounted on the outer surfaceof the conduit folded or rolled upon itself, the ingrowth layer will belocated radial inward from the support layer when the sleeve is unfoldedor unrolled.

Where the tissue connector is intended for connecting with one anothertwo different ends of tubular living tissue, the conduit may have oneflexible sleeve at each of the conduit's first and second ends. Again,the flexible sleeves are preferably located proximately to said firstand second ends.

Of course, it is again preferable to make the flexible sleeve from abiocompatible material, in particular polymer materials similar to thosementioned above in relation to the conduit (except that PEEK would notbe suitable).

The tissue connector may particularly be used and be adapted forconnecting it to at last one of an implantable reservoir, an implantablepump, an implantable motor, an implantable medical device and abiological transplant. The artificial items may even form a part of thetissue connector, either integrally formed therewith or separatelyconnected thereto. The reservoir, pump, motor and/or medical device mayalso be incorporated in the tissue connector between the first andsecond ends of the conduit.

The biological transplant may be any transplant, such as a transplantedheart to be connected by means of the tissue connector to the patient'saorta and/or to other blood vessels (pulmonary arteria etc.).

Instead of being artificial, the aforementioned reservoir may consist ofa biological transplant, but it may as well be made from tissue materialof the patient into whom the reservoir is to be implanted. For instance,the reservoir may be a fecal excrements collecting container, such as aurine bladder or an intestine.

The reservoir may also be a reservoir for medical drugs for thepatient's needs and is preferably adapted to be filled with at least onemedical drug. Such medical drug reservoir may or may not be connected toa medical device, such as an implantable drug delivery device, whichmedical device may additionally include a pump for pumping the drug fromthe reservoir into the patient's body and possibly a motor for the pump.

Any other implantable medical devices may also be connected to theorgans of the patient by means of the tissue connector, with or withouta pump, motor and/or reservoir. Examples of these are an artificialheart, a penile prothesis, an artificial urine bladder, an artificialurethra, an artificial esophagus, an artificial trachea and the like.Examples of biological transplants include a urine bladder, anintestine, a urethra, a ureter, a kidney, a bowel, a heart, anesophagus, a trachea, a blood vessel and the like.

The tissue connector of the present invention can be implanted in ahuman being or animal either in open surgery or by subcutaneous surgery.In either case, the skin will have to be cut before free-dissecting anappropriate location within the patient's body adjacent to the tubularliving tissue and, after the conduit of the tissue connector has beenconnected with one or both ends to the tubular tissue, at least the skinwill have to be sutured at the end of the surgery.

Where the tissue connector is implanted by subcutaneous surgery, thesteps of cutting the skin and free-dissecting the appropriate locationwithin the patient's body comprise the steps of

-   -   inserting a needle-like tube into the patient's body, such as        the patient's thorax or abdomen,    -   filling through said needle gas into the patient's body, i.e.        into the thorax cavity or abdomen cavity,    -   cutting a key-hole,    -   inserting at least one, preferably two, laparoscopic trocars        through the key-hole towards said location,    -   advancing one or more medical instruments and a camera through        the at least one trocar towards said location, i.e. into the        thorax or abdomen, and    -   dissecting an area of the tubular part of living tissue with the        aid of the dissecting tool.    -   The tissue connector may be supplied to said location through        the at least one trocar or through a separate incision.        Aneurysm

In accordance with one embodiment a stimulation device for treating avascular aneurysm of a human or mammal patient is provided. Thestimulation device comprises an implantable electrode adapted to beplaced in close connection to the aneurysm, and is adapted to provide anelectrical stimulation pulse on a wall portion of the aneurysm. Herebyan efficient treatment of the aneurysm can be provided.

In accordance with one embodiment one or several electrode(s) is/areadapted to stimulate multiple stimulation points.

In accordance with one embodiment at least two electrodes are providedand groups of stimulation points individually stimulated.

In accordance with one embodiment a device for delivering electricalstimulation pulse at different time intervals is provided.

In a preferred embodiment, the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe device.

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the device.

In a preferred embodiment, the system comprises a hydraulic operationdevice for operating the device.

In one embodiment, the system comprises comprising a motor or a pump foroperating the device.

The invention also extends to methods for implanting the device and to acomputer program product adapted to control the device.

Any feature in any of the four combinations of features in thecombination embodiments described below may be used in any combinationand furthermore in combination with any other feature or embodimentdescribed in any of the other figures or figure text or descriptions inthis application.

First combination embodiments includes electrical stimulationcomprising:

A medical device including a stimulation device for treating a vascularaneurysm of a human or mammal patient comprising:

-   -   at least one implantable electrode adapted to placed in close        connection to the aneurysm, the at least one electrode being        adapted to provide an electrical stimulation pulse on a wall        portion of the aneurysm.

At least one electrode is adapted to stimulate multiple stimulationpoints. Alternatively at least two electrodes are provided and whereingroups of stimulation points are controllable to be individuallystimulated.

A pulse generator adapted to generate positive and negative electricalstimulation pulses.

Electrical stimulation pulses, which may have a constant current andpreferable the stimulation device deliver the electrical stimulationpulse as pulse train stimulation with breaks to allow the vessel torest.

A stimulation device that deliver the electrical stimulation pulses atdifferent time intervals.

A device preferable delivering the electrical stimulation pulse as apulse width modulated stimulation pulse.

A stimulation device preferable deliver the electrical stimulation pulseduring the systolic phase.

A stimulation device further comprising a monitoring system fordetecting an expansion of the aneurysm. Also to avoid any fast expansionand burst leading to death.

If so said monitoring system may increase intensity and or position ofthe stimulation, when detecting an expansion of the aneurysm.

A method of treating an aneurysm of a mammal patient by providing themedical device according to any feature disclosed herein, comprising thesteps of:

inserting a needle or a tube like instrument into the patient'sabdominal cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said abdominal cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing said medical device, comprising a stimulation device, onto saidthe aneurysmic blood vessel, and

stimulating said aneurysm to increase the tonus of the aneurysm wall.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,comprising the steps of:

inserting a needle or a tube like instrument into the patient'sthoraxial cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said thoraxial cavity,

placing at least two laparoscopic trocars in said cavity.

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing said medical device, comprising a stimulation device, onto saidthe aneurysmic blood vessel, and

stimulating said aneurysm to increase the tonus of the aneurysm wall.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,said method comprising the steps of:

cutting the skin in the abdominal or thoraxial wall of said mammalpatient,

dissecting an area of the aneurysm,

placing said medical device, comprising a stimulation device, onto saidaneurysm, and

stimulating said aneurysm to increase the tonus of the aneurysm wall.

A method of treating an aneurysm of a mammal patient by providing themedical device Including any feature disclosed herein, said methodcomprising the steps of:

cutting the skin of said mammal patient,

dissecting an area of the aneurysm,

placing said medical device, comprising a stimulation device, onto saidaneurysm, and

stimulating said aneurysm to increase the tonus of the aneurysm wall.

Additionally a computer program product comprising computer programsegments that when executed on a computer causes the computer togenerate a pattern of signals for an implantable electrode adapted toplaced in close connection to an aneurysm, the at least one electrodebeing adapted to provide an electrical stimulation pulse on a wallportion of the aneurysm.

A device including a digital storage medium comprising the computerprogram product.

Second combination embodiments includes a hydraulic system puttingpressure on the aneurysm comprising:

A device for treating an aneurysm of a human or mammal patientcomprising:

-   -   An implantable member adapted to hold fluid, wherein said member        is adapted to be placed in connection with a blood vessel having        the aneurysm, the member being adapted to exercise a pressure on        the aneurysm of said blood vessel.

A device preferable adapted to prevent or reduce an expansion of saidaneurysm.

A device adapted to be postoperatively adjusted. The device is normallynon-invasively adjustable.

A device preferable adapted to perform self adjustments of the pressureapplied onto said aneurysm within a predetermined treatment interval.

A device normally comprising a control unit and a sensor, the controlunit being adapted to control pressure adjustments of based on a signalgenerated by the sensor.

The sensor may comprise any type of sensor. Preferable a pressureregulator is adapted to regulate the pressure in the member, wherein thepressure regulator preferable is adapted to even out the difference inpressure in the implantable member during the systolic and diastolicphase for reducing the pressure difference or providing a substantiallyeven outside pressure on the aneurysm. The pressure regulator maycomprise pressure tank.

A implantable member which is alternatively Y-shaped, wherein theimplantable Y-shaped member normally is adapted to be placed at theAorta Bifurcation

A pressure regulator in one embodiment comprises an expandable firstreservoir.

The expandable first reservoir preferable is spring loaded.

A device wherein the pressure regulator in a preferred embodimentcomprises a pump.

A device further comprising a second reservoir and a pump adapted tomove liquid between the first and second reservoirs.

A device wherein preferable said first reservoir has a predeterminedoptimal pressure regulation volume treatment interval and wherein saidpump is adapted to pump liquid from the first to the second reservoir tokeep said first reservoir within said regulation interval, when saidaneurysm expands and to pump liquid from said implantable member intosaid first reservoir.

A device preferable provides a pressure equal or less than the diastolicblood pressure of a treated patient.

A device preferable adapted to increase the pressure on the blood vesselwhen the aneurysm expands.

A device comprising a control device adapted to increase the pressure onthe blood vessel when the aneurysm expands more than a predeterminedvalue, preferable during a time period.

A control unit adapted to control the expansion of said aneurysm bycontrolling the pressure applied on the blood vessel when the aneurysmexpands.

A device preferable further comprising a sensor for sensing an expansionof the aneurysm.

A device preferable further comprising a volume control unit adapted todirectly or indirectly control the volume in the implantable memberbased on a signal generated by the sensor for controlling an expansionof the aneurysm, wherein normally said volume control unit controls thevolume in the implantable member based on a signal indicative of: flowof fluid from said implantable member or pressure in said fluid filledin said implantable member.

A device wherein the implantable member is divided into a plurality ofsub-reservoirs.

A device wherein the sub-reservoirs are provided axially along the bloodvessel or radially along the blood vessel.

A device wherein preferable at least one reservoir is located above saidaneurysm and one reservoir is located below said aneurysm.

A device further comprising a logic circuitry for determining when theaneurysm is expanding based on the signal from the sensor.

A device further comprising an electrical pulse generator adapted toprovide electrical signals for stimulation of the aneurysm wall viaelectrodes located on the inside of the implantable member.

A control unit adapted to vary to position of the electrical stimulationsignals for stimulation of the aneurysm.

A method of treating an aneurysm of a mammal patient by providing themedical device according to any feature disclosed herein, comprising thesteps of:

inserting a needle or a tube like instrument into the patient'sabdominal cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said abdominal cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and adjustingthe pressure the device exerts onto said aneurysm.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,comprising the steps of:

inserting a needle or a tube like instrument into the patient'sthoraxial cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said thoraxial cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and

adjusting the pressure said device exerts onto said aneurysm.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,said method comprising the steps of:

cutting the skin in the abdominal or thoraxial wall of said mammalpatient,

dissecting an area of the aneurysm,

placing said device onto said aneurysm, and

starting the stimulation device and adapted to adjust any parameterrelated to said stimulation.

adjusting the pressure said device exerts onto said aneurysm.

A computer program product comprising computer program segments thatwhen executed on a computer causes the computer to control the pressureapplied by an implantable member adapted to hold fluid and adapted to beplaced in connection with a blood vessel having an aneurysm. A digitalstorage medium comprising the computer program product.

Third combination embodiments includes a mechanical system puttingpressure on the aneurysm including any feature in any combination,comprising:

A device for treating a vascular aneurysm of a human or mammal patientcomprising:

-   -   An implantable member adapted to be placed in connection with a        blood vessel having an aneurysm for providing a pressure from        outside the blood vessel, the device being adapted to be        adjusted postoperatively.

A device preferable adapted to prevent or reduce an expansion of saidaneurysm.

A device adapted to monitor an expansion of said aneurysm.

The device is preferable adjustable non-invasively.

A device adapted to perform self adjustments of the pressure appliedonto said aneurysm within a predetermined treatment interval.

A device comprising an control unit and a sensor, wherein the controlunit is adapted to control the pressure applied onto said aneurysm basedon said signal generated by the sensor.

A device, wherein the surface of the member facing the blood vessel isadapted to exercise pressure on the blood vessel.

A device, wherein the pressure on the blood vessel is mechanicallyexercised.

A, wherein the mechanically exercised pressure is controlledhydraulically.

A device, wherein mechanical pressure on the blood vessel is directly orindirectly exercised by a motor or a pump.

A, wherein the implantable member is generally cylindrical

A device, wherein the implantable member comprises a number of segmentsbeing individually adjustable.

A device, wherein the implantable member is a Y-shaped member

A device, wherein the implantable Y-shaped member is adapted to beplaced at the Aorta Bifurcation.

A pressure regulating system adapted to even out the difference inpressure in the implantable reservoir in the systolic and diastolicphase to reduce the differences or to achieve a substantially evenpressure affecting said aneurysm from the outside of said blood vessel.

A device, wherein the implantable member is an elastic member.

A device, wherein the elastic member is a band

A device, wherein the elastic member is adapted to apply a pressure ontosaid aneurysm and has an expansion interval wherein the pressure appliedis substantially constant or within an interval for treating andreducing expansion of the aneurysm.

A device, wherein the implantable member is spring loaded.

A device according to claim 1, wherein the implantable member ishydraulically operated.

A device, wherein the implantable member is pneumatically operated

A device, wherein the implantable member is adapted to exert anessentially constant pressure or a pressure reducing the pressuredifference, caused by the changes in blood pressure in said bloodvessel, on the aneurysm.

A device, wherein the provided pressure is equal or less than thediastolic blood pressure of a treated patient.

A device further comprising a control unit adapted to increase thepressure on the blood vessel when the aneurysm expands.

A device comprising a control device adapted to Increase the pressure onthe blood vessel when the aneurysm expands more than a predeterminedvalue.

A device comprising a control device adapted to increase the pressure onthe blood vessel when the aneurysm expands more than a predeterminedvalue during a time period.

A device, further comprising a sensor or a measuring device for sensingan expansion of the aneurysm.

A device, further comprising logic circuitry for determining when theaneurysm is expanding based on a signal from a sensor or measuringdevice.

A device, further comprising an electrical pulse generator adapted toprovide stimulation of the aneurysm wall via electrodes located on theinside of the implantable member.

A method of treating an aneurysm of a mammal patient by providing themedical device according to any feature disclosed herein, comprising thesteps of:

inserting a needle or a tube like instrument into the patient'sabdominal cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said abdominal cavity,

placing at least two laparoscopic trocars in said cavity.

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and adjustingthe pressure the device exerts onto said aneurysm.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,comprising the steps of:

inserting a needle or a tube like instrument into the patient'sthoraxial cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said thoraxial cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and

adjusting the pressure said device exerts onto said aneurysm.

An alternative method of treating an aneurysm of a mammal patient byproviding the medical device including any feature disclosed herein,said method comprising the steps of:

cutting the skin in the abdominal or thoraxial wall of said mammalpatient,

dissecting an area of the aneurysm,

placing said device onto said aneurysm, and

starting the stimulation device and adapted to adjust any parameterrelated to said stimulation.

adjusting the pressure said device exerts onto said aneurysm.

A computer program product comprising computer program segments thatwhen executed on a computer causes the computer to control the pressureapplied by an implantable member adapted to be placed in connection witha blood vessel having an aneurysm.

A digital storage medium comprising the computer program product.

Fourth combination embodiments includes a monitoring/sensor systemputting pressure on the aneurysm including any feature in anycombination, comprising:

A device for monitoring an aneurysm of a human or mammal patientcomprising:

A sensor placed in relation to a wall portion of the aneurysm forgenerating a signal corresponding to a parameter related to the aneurysmor the treatment of the aneurism.

A device, wherein the parameter corresponds to the size of the aneurysm.

A device, wherein the parameter corresponds to the diameter of theaneurysm.

A device wherein the sensor is a gauge sensor.

A device wherein the parameter corresponds to a pressure.

A device wherein the pressure corresponds to a pressure from a hydrauliccuff provided around the aneurysm.

A device wherein the pressure corresponds to a pressure from amechanical implantable member provided around the aneurysm.

A device wherein the pressure corresponds to a pressure in a bloodvessel.

A device wherein the sensor is adapted to measure the pressure exertedon an implantable member provided around the aneurysm.

A device wherein the sensor is adapted to measure the volume of ahydraulic implantable member.

A method of treating an aneurysm of a mammal patient by providing themedical device, comprising the steps of:

inserting a needle or a tube like instrument into the patient'sabdominal cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said abdominal cavity,

placing at least two laparoscopic trocars in said cavity.

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and

monitoring the expansion of the aneurysm by measuring the expansion theaneurysm exerts onto the device.

A method of treating an aneurysm of a mammal patient by providing themedical device, comprising the steps of:

inserting a needle or a tube like instrument into the patient'sthoraxial cavity,

using the needle or tube like instrument to fill a part of the patient'sbody with gas and thereby expanding said thoraxial cavity,

placing at least two laparoscopic trocars in said cavity,

inserting a camera through one of the laparoscopic trocars into saidcavity,

inserting at least one dissecting tool through one of said at least twolaparoscopic trocars,

dissecting an area of an aneurysm of a blood vessel,

placing the device onto said the aneurysmic blood vessel, and

monitoring the expansion of the aneurysm by measuring the expansion theaneurysm exerts onto the device.

A method of treating an aneurysm of a mammal patient by providing themedical device, said method comprising the steps of:

cutting the skin in the abdominal or thoraxial wall of said mammalpatient,

dissecting an area of the aneurysm,

placing said device onto said aneurysm, and

monitoring the expansion of the aneurysm by measuring the expansion theaneurysm exerts onto the device.

A method of treating an aneurysm of a mammal patient by providing themedical device, said method comprising the steps of:

cutting the skin of said mammal patient,

dissecting an area of the aneurysm,

placing said device onto said aneurysm, and

monitoring the expansion of the aneurysm by measuring the expansion theaneurysm exerts onto the device.

Please note that any embodiment, of a device or system, or part ofembodiment as well as any method or part of method could be combined inany way. All examples herein should be seen as part of the generaldescription and therefore possible to combine in any way in generalterms.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B, 1C, 1D and 1E schematically illustrate different states ofoperation of a general embodiment of an apparatus according to thepresent invention.

FIGS. 1F, 1G and 1H illustrate different states of operation of amodification of the general embodiment.

FIGS. 1I, 1K and 1L illustrate an alternative mode of operation of themodification of the general embodiment.

FIG. 2 is a longitudinal cross-section of a preferred embodiment of theapparatus according to the invention including a constriction device andan electric stimulation device.

FIG. 3 is a cross-section along line III-III in FIG. 2.

FIG. 4 is the same cross-section shown in FIG. 3, but with the apparatusin a different state of operation.

FIGS. 5A, 5B and 5C are cross-sections of the embodiment of FIG. 2showing different states of operations with the apparatus applied on atissue wall of a patient's organ.

FIGS. 6A, 6B and 6C are cross-sections of a modification of theembodiment of FIG. 2 showing different states of operations with theapparatus applied on a tissue wall of a patient's organ.

FIGS. 7A and 7B show different steps of an electric stimulation modeperformed by the apparatus of FIG. 2, while the apparatus isconstricting a tissue wall of a patient's organ.

FIG. 8A is a pulse/time diagram showing electric stimulation pulsesgenerated by the apparatus of the invention for stimulating a tissuewall of a patient's organ.

FIG. 8B is pulse/time diagram showing a modification of the electricstimulation shown in FIG. 8A, in which pulses of mixed frequenciesand/or amplitudes are employed.

FIGS. 9A and 9B show two pulse/time diagrams, respectively, representingelectric stimulation of two different areas of the tissue wall withpulses forming pulse trains.

FIGS. 10A and 10B show the pulse/time diagrams of FIGS. 9A and 9B withmodified pulse trains.

FIG. 11A is a longitudinal cross-section of an embodiment of theapparatus of the invention including a thermal stimulation device,wherein the apparatus is constricting a tissue wall of a patient'sorgan.

FIG. 11B is the same embodiment of FIG. 11A with the thermal stimulationdevice activated.

FIG. 12A is a schematic view of hydraulic operation means suited foroperating the constriction device of the embodiments of FIGS. 2-11.

FIG. 12B shows the embodiment of FIG. 12A with the constriction deviceconstricting a tissue wall of a patient's organ.

FIG. 13A is a schematic view of mechanical operation means suited foroperating the constriction device of the embodiments of FIGS. 2-11.

FIG. 13B shows the embodiment of FIG. 13A with the constriction deviceconstricting a tissue wall of a patient's organ.

FIG. 13C shows a modification of the embodiment of FIG. 13B.

FIG. 14A illustrates the apparatus of the invention applied on the smallintestines of a colostomy patient having a stoma opening in the abdomen.

FIG. 14B illustrates the apparatus of the invention applied on the smallintestines of a colostomy patient having the small intestines ending atthe patient's anus.

FIG. 15 is a schematic sectional view of a mechanically operablenon-inflatable constriction device for use in accordance with theinvention.

FIGS. 16 and 17 are cross-sectional views taken along the lines XVI-XVIand XVII-XVII, respectively, of FIG. 15.

FIG. 18 schematically shows an alternative design of the embodiment ofFIG. 15:

FIG. 19 schematically illustrates a motor arrangement for the designaccording to FIG. 18;

FIGS. 20 and 21 are schematic sectional views of two alternative designsof non-inflatable constriction devices of the invention.

FIGS. 22 and 23 illustrate a fully open and a reduced constrictionopening, respectively, of the embodiment of FIG. 21;

FIG. 24 is a schematic view of a further alternative design of anon-inflatable constriction device of the invention.

FIGS. 25 and 26 illustrate a fully open and a reduced constrictionopening, respectively, of the embodiment of FIG. 24;

FIG. 27 is a schematic view of another alternative design of anon-inflatable constriction device of the invention.

FIGS. 28 and 29 are schematic sectional views, respectively, of yetanother alternative design of a non-inflatable constriction device ofthe invention.

FIG. 30A is a schematic view of a hydraulically operable inflatableconstriction device for use in accordance with the invention.

FIG. 30B is the same embodiment shown in FIG. 30A with the constrictiondevice inflated.

FIGS. 31A, 31B, 31C and 31D are block diagrams illustrating fourdifferent principles for hydraulic operation of the constriction deviceshown in FIG. 30A.

FIG. 32 is a cross-sectional view of a reservoir having a variablevolume controlled by a remote control motor.

FIGS. 33A and 33B are perspective views of a reverse servo in accordancewith a particular embodiment of the hydraulic operation principle shownin FIG. 31C.

FIG. 34 is a schematic view of another hydraulically operableconstriction device for use in accordance with the invention.

FIG. 35A illustrates the constriction device of FIG. 34 in a constrictedstate.

FIG. 35B illustrates the constriction device of FIG. 34 in a releasedstate.

FIGS. 36A-36E schematically illustrate different operation stages of anembodiment of the invention, in which a constriction device and astimulation device co-operate to move the fluid and/or other bodilymatter in the lumen of a patient's organ.

FIG. 37 is a schematic block diagram illustrating a general embodimentof the apparatus of the invention, in which energy is transferred toenergy consuming components of the apparatus implanted in the patient.

FIGS. 38 to 49 are schematic block diagrams illustrating twelveembodiments, respectively, based on the general embodiment shown in FIG.37, wherein wireless energy is transmitted from outside a patient's bodyto energy consuming components of the apparatus implanted in thepatient.

FIG. 50 illustrates an energy-transforming device in the form of anelectrical junction element for use in the apparatus of the presentinvention.

FIG. 51 is a block diagram illustrating control components of anembodiment of the invention.

FIG. 52 is a schematic view of exemplary circuitry of an embodiment ofthe invention, in which wireless energy is transformed into a current.

FIGS. 53A-53C schematically illustrate different operation stages ofanother embodiment of the invention of the type shown in FIG. 2, inwhich a constriction device and a stimulation device co-operate to movethe fluid and/or other bodily matter in the lumen of a patient's organ.

FIGS. 54A-54B schematically illustrate different operation stages ofanother embodiment of the invention of the type shown in FIGS. 36A-36E,in which a constriction device and a stimulation device co-operate tomove the fluid and/or other bodily matter in the lumen of a patient'sorgan.

FIG. 55A is a schematic view of another mechanically operablenon-inflatable constriction device for use in accordance with theinvention.

FIG. 55B shows the constriction device of FIG. 55A in a constrictedstate.

FIG. 55C is an end view of the embodiment of FIG. 55B.

FIG. 56 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of wireless energy used for the operationof the constriction/stimulation unit as described above.

FIG. 57 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 58 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the constriction/stimulation unit as described above.

FIG. 59 is a circuit for the arrangement shown in FIG. 19, according toa possible implementation example.

FIG. 60A illustrates the apparatus of the invention applied on the smallintestines of a colostomy patient having a stoma opening in the abdomen.

FIG. 60B illustrates the apparatus of the invention applied on the smallintestines of a colostomy patient having the small intestines ending atthe patients anus.

FIG. 61A illustrates the apparatus of the invention applied on theurethra of a urinary incontinent patient.

FIG. 61B illustrates the apparatus of the invention applied on theureter of a urinary incontinent patient.

FIG. 61C illustrates the apparatus of the invention applied on theurinary bladder.

FIG. 61D illustrates the embodiment of FIG. 61C combined with theembodiment shown in FIG. 61A.

FIG. 62A illustrates the apparatus of the invention applied on thestomach of an obese patient surgically modified by AGB (AdjustableGastric Banding).

FIG. 62B is a front view of a detail of the apparatus shown in FIG. 62A.

FIG. 63 illustrates the apparatus of the invention applied on thestomach of an obese patient surgically modified by VBG (Vertical BandedGastroplasty).

FIG. 64A illustrates the apparatus of the invention applied around thecorpus cavernosum of an impotent patient.

FIG. 64B Illustrates the apparatus of the invention with twoconstriction/stimulation units applied around respective exit veins fromthe patient's penis.

FIG. 65A illustrates the apparatus of the invention implanted in thebody of a female patient suffering from sexual dysfunction.

FIG. 65B illustrates the apparatus of the invention with twoconstriction/stimulation units applied around respective exit veins ofthe patient's erectile tissue.

FIG. 65C illustrates the apparatus of the invention with twoconstriction/stimulation units applied around respective corporacavernosa of the patient's erectile tissue.

FIG. 66 illustrates the apparatus of the invention applied on theuterine tube of a female patient to control egg movement.

FIG. 67 illustrates the apparatus of the invention applied on a uterinetube of a female patient to control sperm movement

FIG. 68 is a sectional view through a constriction device of theapparatus shown in FIG. 67 configured to restrict or stop the flowthrough the uterine tube.

FIG. 69 A-C illustrate the constriction device of FIG. 68 in differentinterrupting stages.

FIG. 70 A-D show a second embodiment of a constriction device of theapparatus shown in FIG. 67.

FIG. 71 A-E disclose one particular embodiment of the invention using asperm pump to such sperms up from the uterus into the uterine tube.

FIG. 72A schematically shows an embodiment of a system for controlling aflow of blood with wireless control.

FIGS. 72B and 72C show different positions for a constriction devicecomprised in a system for controlling a flow of blood.

FIG. 73 is a schematic general view of a human being having a cuffimplanted for treating an aneurysm located on the aorta in the abdomenclose to the Y-bifurcation extending to the legs.

FIG. 74A shows a schematic detail of the apparatus indicated in FIG. 73.

FIG. 74B shows a detail of the cuff when placed on the Y-bifurcation.

FIG. 74C shows a cross-sectional view of the cuff in FIG. 74B.

FIG. 75 illustrates a system for treating, stabilizing or monitoring ananeurysm, wherein the system includes an apparatus according to anembodiment of the invention implanted in a patient

FIGS. 76-89 schematically show various embodiments of the system forwirelessly powering the apparatus shown in FIG. 75.

FIGS. 90A to 90D illustrate the apparatus when implanted in a malepatient for contraception.

FIGS. 91A-91 M schematically show an example of the apparatus accordingto the invention when implanted in a male patient for contraception.

FIG. 92 illustrates the apparatus of the invention applied on the commonbile duct of a gallstone patient.

FIG. 93A illustrates an embodiment of a pregnancy promotion apparatusaccording to the invention applied on the oviducts of a female patient,wherein the apparatus is in a non-restricting operating state.

FIG. 93B is a view similar to that of FIG. 93A, but wherein theapparatus is in a restricting operating state.

FIG. 94A illustrates the embodiment of FIG. 93A with remote controlapplied on the oviducts of a female patient, wherein the apparatus is ina non-restricting operating state.

FIG. 94B is a view similar to that of FIG. 94A, but wherein theapparatus is in a restricting operating state.

FIG. 95A illustrates an embodiment of a pregnancy inhibition apparatusaccording to the invention applied on the oviducts of a female patient,wherein the apparatus is in a non-restricting operating state.

FIG. 95B is a view similar to that of FIG. 95A, but wherein theapparatus is in a restricting operating state.

FIG. 96A illustrates the embodiment of FIG. 95A with remote controlapplied on the oviducts of a female patient, wherein the apparatus is ina non-restricting operating state.

FIG. 96B is a view similar to that of FIG. 96A, but wherein theapparatus is in a restricting operating state.

FIGS. 97A to 97F schematically an apparatus according to the inventionimplanted in a human.

FIG. 97G illustrates a system for treating a disease, wherein the systemincludes an apparatus of any one of FIGS. 97A to 97F implanted in apatient

FIGS. 98A-98C illustrate an apparatus of the invention for treating afemale patient suffering from sexual dysfunction, wherein the apparatusincludes a stimulation device implanted in the patient.

FIGS. 99A-99D illustrate an apparatus of the invention for treating afemale patient suffering from sexual dysfunction, wherein the apparatusincludes a restriction device implanted in the patient.

FIG. 100A shows a system according to the present invention, wherein thereservoir is formed by a plurality of bent portions of human intestine,with laterally adjacent sections thereof being cut open along theirmutual contact line and the resulting upper halfs and lower halfsthereof being interconnected so as to form a reservoir. The flow controldevice consists of one exit valve implanted within the intestine, andthe intestine exits the patients abdominal wall through a surgicallycreated stomy. An external manually driven suction pump is used foremptying the reservoir, wherein a conduit on the front end of the pumpis inserted from outside the patient's body into the intestine, therebymechanically urging the exit valve to open. Accordingly, the structureof the exit valve is resilient so as to close automatically.

FIG. 100B shows a variant of FIG. 100A, wherein the exit valve is placedoutside of the intestine.

FIG. 101A shows a variant to FIG. 100A. Instead of being implantedinside the patient's intestine, the exit valve makes part of anartificial intestine section, one end of which forms the stomy openingand the other end of which is affixed by means of a ring-and-bulgeconnector to the cross-sectional opening of the intestine.

FIG. 101B shows an enlarged view of the ring-and-bulge connectionbetween the artificial intestine section and the patient's intestine.

FIG. 101C shows an embodiment where an electrical flow control device isplaced outside the reservoir.

FIG. 101D shows the device according to FIG. 101C in a top view.

FIG. 101E shows an embodiment where a mechanical flow control device isplaced outside the reservoir.

FIG. 101F shows the device according to FIG. 101E in a top view.

FIG. 101G shows an embodiment where a hydraulic flow control device isplaced outside the reservoir.

FIG. 101H shows the device according to FIG. 101G in a top view.

FIGS. 102A and 102B show an alternative to the ring-and-bulgeconnection. Here, the artificial intestine section comprises a conduitand a flexible sleeve which axially extends and closely fits around theouter surface of the conduit. The sleeve is rolled upon itself and canbe unrolled such that a part of the intestine is located intermediatethe sleeve and the conduit.

FIGS. 103A and 103B show an alternative to the connection in FIGS. 102Aand 102B. Instead of unrolling the sleeve, it is simply pulled over theintestine.

FIGS. 103C and 103D show another sleeve connection. Here, the sleeve ismounted on the outer surface of the conduit so as be foldable uponitself. By folding the flexible sleeve upon itself, a part of theintestine is located intermediate the folded sleeve.

FIGS. 104A and 104B show a combined connection comprising both thefunction of the ring-and-bulge connection and the function of the sleeveconnection of FIGS. 102A and 102B. Combinations of the ring-and-bulgeconnection with the sleeve connections of FIG. 103A, 103B or 103C, 103Dare likewise possible.

FIG. 105 generally shows that the artificial intestine section may beaffixed with both open ends to cross-sectional openings created in thepatient's intestine, intended for cases where the downstream open endportion of the artificial intestine section is not intended to form astomy or anus. The artificial intestine section here is shown withoutany internal components and may comprise a reservoir for intestinalcontents, one or more valves, a pump and/or any other flow controldevice. The connection of the open end portions of the artificialintestine section to the patient's intestine is shown in FIG. 105 to bemade by sleeve connections, here involving a single sleeve.

FIG. 106A shows an embodiment with an artificial reservoir connected toa lateral opening in the patient's intestine wall, a single opening ofthe reservoir. An entry valve and an exit valve are arranged at thepatient's intestine upstream and downstream of the reservoir. A stomyexiting the patient's abdominal wall has been surgically created fromthe patient's small or large intestine. The reservoir is mounted with apump in a common housing and the pump and the entry and exit valves arecontrolled by means of a control device, of which a part is implantedinside the patient's body. Data are transmitted wirelessly between theexternal part and the implanted part of the control unit. In addition,energy is wirelessly transmitted to an accumulator also implanted in thepatient's body and galvanically connected here to the valves and pump.

FIG. 106B shows the system of FIG. 106A connected to the patient's anusrather than to a surgically created stomy.

FIGS. 107A and 107B show a specific embodiment, wherein the pump and thereservoir are comprised in a common housing and the pump comprises amoveable piston with a front end of the piston extending into thereservoir such that a volume of the reservoir is reduced uponadvancement of the piston. The piston is spring loaded so as to urge thepiston into a normally retracted position. Furthermore, entry and exitvalves are provided in this embodiment, here being realized as flapvalves. The flap valves are controlled so that one valve is open whilethe other one is closed.

FIGS. 108A and 108B show a system similar to the one of FIGS. 107A and107B, and FIGS. 106A and B, with a single opening in the reservoirconnected to the intestine. However, here the entry and exit valvescomprise bellows acting on the intestine from the outside so as to closethe intestine by compression. In FIG. 108A the bellows of the exit valveare expanded to compress the intestine at the downstream side of thereservoir, whereas in FIG. 108B the intestine is closed by means of thebellows of the entry valve upstream of the reservoir so that thereservoir can be emptied by advancing the piston of the pump.

FIG. 109 shows an embodiment schematically, wherein the artificialintestine section by-passes a section of the patients intestine, theintestine being closed by sewing so as to direct intestinal contenttowards the artificial intestine section. The enlarged area of theartificial intestine section represents any kind of element acting onthe intestinal contents within the artificial intestine section, such asa reservoir, one or more valves, a pump or any other flow controldevice, possibly including a motor, and the like. Furthermore, a batteryimplantable in the patient's body and preferably rechargeable providesthe artificial intestine section with energy. The artificial intestinesection is wirelessly controlled and the battery, if rechargeable,wirelessly charged. A sensor implanted on or within the intestinedelivers data on the physical conditions within the intestine forcontrolling the artificial intestine section.

FIGS. 110A to 110C show a specific embodiment, wherein the artificialreservoir by-passes a section of the patient's intestine. The reservoirhas a flexible wall and a pump implanted in the patient's body separatebut in close proximity to the reservoir is used to empty the reservoir.The pump is actuated by means of a subcutaneously implanted, manuallyoperable switch.

FIGS. 111A and 111B show a structure similar to the one of FIGS. 110A to110C, however, with the pump and the reservoir being fixedly connectedto one another. The reservoir is formed by a bellow having an end wallclosing the bellow at one end thereof. The end wall makes part of thepump such that a volume of the bellow can be reduced upon advancement ofthe end well. The bellow is made of a resilient material so as to urgethe bellow into a normally extended position.

FIGS. 112A and 112B show a variant to FIGS. 111A and 111B. Here, thepump and reservoir are integrally combined. The pump is manuallyoperable and subcutaneously mounted so as to be operable from theoutside of the patient's body.

FIGS. 113A and 113B likewise show a variant to the system shown in FIGS.111A and 111B. While in the system of FIGS. 111A, 111B the pump isautomatically driven, such as by an integrated motor, and activated viaremote control, the system in FIGS. 113A and 113B is again manuallyoperable in that the manually operable pump is mounted subcutaneously.

FIGS. 114A to 114C show a plurality of cooperating valves implantedinside the patient's body and outside the patient's intestine. Each ofthe valves comprises an electrical stimulation device adapted toelectrically stimulate muscle or neural tissue of an intestine sectionso as to cause at least partial contraction of the intestine section.For that purpose, the stimulation device comprises at least oneelectrode adapted to apply electric pulses to the intestine section.While instead of the three stimulation devices shown, a singlestimulation device would be sufficient for opening and closing theintestine, the arrangement of the plurality of stimulation devices isadapted to stimulate different portions of the intestine section overtime. The function of the three stimulation devices may also be combinedin one integral unit. The direction of natural intestinal contents flowis indicated by arrows. The different portions of the intestine sectionin a wavelike manner may be made in a direction opposite to the naturalintestinal contents flow, as shown in FIGS. 114A to 114C, so as to closethe intestine section. The stimulation in the wavelike manner may alsobe made in the direction of natural intestinal contents flow to supportemptying of the intestine or reservoir.

FIGS. 115A to 115C show the stimulation devices of FIGS. 114A to 114C incombination with constriction devices, such as the bellow valvesdescribed in relation to FIGS. 108A and 108B, for at least partlyconstricting the intestine section mechanically. Complete constrictionis obtained by additional electrical stimulation of the respectiveintestine sections. The constriction devices may be released in order toallow intestinal contents to flow through.

FIG. 116a shows a system according to the present invention with anartificial intestine section being implanted inside a patient's body andhaving a first open end portion connected to a surgically createdopening in the patient's intestine, more specifically to a lateralopening in a wall of the patient's intestine. The second open endportion exits the patient's abdominal wall forming a stomy. Theartificial intestine section is here shown as a black box and includesat least one energy consuming part, such as one or more valves, a pumpand/or any other flow control device, a motor for driving the same,possibly in connection with a reservoir. An accumulator is implantedalong with the artificial intestine section and can be wirelesslycharged from outside the patient's body. The energy is here galvanicallytransmitted from the accumulator to the artificial intestine section.

FIG. 116B shows a system corresponding to the one shown in FIG. 1,however, with the energy being transmitted wirelessly from theaccumulator to the artificial intestine section.

FIG. 116C shows a system corresponding to the one shown in FIG. 1,however, with the second open end portion of the artificial intestinesection exiting the patient's anus.

FIG. 117 shows a system where both the first and second open endportions of the artificial intestine section are attached to surgicallycreated lateral openings in a wall of the patient's small and/or largeintestine. The downstream part of the intestine exits the patient'sabdominal wall forming a surgically created stomy. The downstream partof the intestine may as well exit through the patient's anus.

FIG. 118 shows a similar system with the difference that the second openend portion is connected to a cross-sectional opening of the patient'sintestine, further leading to the surgically created stomy. Thedownstream part of the intestine may as well exit through the patient'sanus.

FIG. 119 shows an embodiment of the artificial intestine section with anartificial reservoir and an entry valve and exit valve arranged upstreamand downstream of the reservoir. The reservoir is mounted with a pump ina common housing and the pump and the entry and exit valves arecontrolled by means of a control device, of which a part is implantedinside the patient's body. Data are transmitted wirelessly between theexternal part and implanted part of the control unit. In addition,energy is wirelessly transmitted to the artificial intestine section orto an accumulator also implanted in the patient's body and galvanicallyconnected here to the valves and pump.

FIGS. 120A and 120B show a first embodiment of the structure of FIG. 119in more detail. The pump comprises a moveable piston with a front end ofthe piston extending into the reservoir such that a volume of thereservoir is reduced upon advancement of the piston. The piston isspring loaded so as to urge the piston into a normally retractedposition. Furthermore, entry and exit valves are here realized as flapvalves. The flap valves are controlled so that one valve is open whilethe other one is closed.

FIGS. 121A and 121B show a system similar to the one of FIGS. 120A and120B. However, here the entry and exit valves comprise bellows acting onthe intestine from the outside so as to close the intestine bycompression. In FIG. 8A the bellows of the exit valve are expanded tocompress the artificial intestine section at the downstream side of thereservoir, whereas in FIG. 121B the artificial Intestine section isclosed by means of the bellows of the entry valve upstream of thereservoir so that the reservoir can be emptied by advancing the pistonof the pump.

FIG. 122 shows an embodiment schematically, wherein the artificialintestine section by-passes a section of the patient's intestine, theintestine being closed by sewing so as to direct intestinal contenttowards the artificial intestine section. The enlarged area of theartificial intestine section represents any kind of element acting onthe intestinal contents within the artificial intestine section, such asa reservoir, one or more valves, a pump or any other flow controldevice, possibly including a motor, and the like. Furthermore, a batteryimplantable in the patient's body and preferably rechargeable providesthe artificial intestine section with energy. The artificial intestinesection is wirelessly controlled and the battery, if rechargeable,wirelessly charged. A sensor implanted on or within the intestinedelivers data on the physical conditions within the intestine forcontrolling the artificial intestine section.

FIGS. 123A to 123C show an embodiment, where the artificial intestinesection comprises a reservoir with a flexible wall. A pump is implantedin the patient's body separate but in close proximity to the reservoirand is used to empty the reservoir. The pump is actuated by means of asubcutaneously implanted, manually operable switch.

FIGS. 124A and 124B show a structure similar to the one of FIGS. 123A to1230, however, with the pump and the reservoir being fixedly connectedto one another. The reservoir is formed by a bellow having an end wallclosing the bellow at one end thereof. The end wall makes part of thepump such that a volume of the bellow can be reduced upon advancement ofthe end wall. The bellow is made of a resilient material so as to urgethe bellow into a normally extended position

FIGS. 125A to 125C show a plurality of cooperating valves implantedinside the patient's body and outside the patient's intestine. These canbe positioned behind and/or in front of the artificial intestine piecealong the patient's natural Intestine. Each of the valves comprises anelectrical stimulation device adapted to electrically stimulate muscleor neural tissue of an intestine section so as to cause at least partialcontraction of the intestine section. For that purpose, the stimulationdevice comprises at least one electrode adapted to apply electric pulsesto the intestine section. While instead of the three stimulation devicesshown, a single stimulation device would be sufficient for opening andclosing the intestine, the arrangement of the plurality of stimulationdevices is adapted to stimulate different portions of the intestinesection over time. The function of the three stimulation devices mayalso be combined in one integral unit. The direction of naturalintestinal contents flow is indicated by arrows. The different portionsof the intestine section in a wavelike manner may be made in a directionopposite to the natural intestinal contents flow, as shown in FIGS. 125Ato 125C, so as to close the intestine section. The stimulation in thewavelike manner may also be made in the direction of natural intestinalcontents flow to support emptying of the intestine or reservoir.

FIGS. 126A to 126C show the stimulation devices of FIGS. 125A to 125C incombination with constriction devices, such as the bellow valvesdescribed in relation to FIGS. 121A and 121B, for at least partlyconstricting the intestine section mechanically. Complete constrictionis obtained by additional electrical stimulation of the respectiveintestine sections. The constriction devices may be released in order toallow intestinal contents to flow through.

FIGS. 127A and 127B show a system comprising the artificial intestinesection connected to a cross-sectional opening of the patient'sintestine and having a valve as shown in FIG. 125 or 126 arranged aroundthe patient's intestine upstream of the artificial intestine section.Energy and/or data is transmitted wirelessly.

FIG. 128 shows the structure of an open end portion of the artificialintestine section for attaching the artificial intestine section to alateral opening in the patient's intestine by means of a shoulderportion formed around the end portion. The end portion is sewn to theintestine and may additionally or alternatively be stapled and/or gluedto the intestine.

FIG. 129 shows an improved structure for lateral attachment to theintestine, wherein the shoulder portion is split into an upper and alower shoulder portion forming a gap to accommodate intestinal walltissue therein. The surface area of the upper shoulder portion is largerthan the surface area of the lower shoulder portion.

FIG. 130 shows an enlarged view of a ring-and-bulge connection by whichthe artificial intestine section and the patient's downstream intestinalpart are connected, as shown in FIG. 118.

FIGS. 131A and 131B show the ring-and-bulge connection of FIG. 130 incombination with a sleeve. The sleeve is rolled upon itself and can beunrolled such that a part of the intestine is located intermediate thesleeve and the conduit. Thereafter, the ring is pushed over the sleeveagainst the bulge.

FIGS. 132A and 132B show a connection of the artificial intestinesection to a cross-sectional opening of the patient's intestine similarto the connection shown in FIGS. 131A and 131B, however, without thebulge and the ring.

FIGS. 133A and 133B show an alternative to the connection in FIGS. 132Aand 132B. Instead of unrolling the sleeve, it is simply pulled over theintestine.

FIGS. 134A and 134B show another sleeve connection. Here, the sleeve ismounted on the outer surface of the open end portion so as to befoldable upon itself. By folding the flexible sleeve upon itself, a partof the intestine is located intermediate the folded sleeve.

FIG. 135 shows a system according to the present invention with anartificial intestine section being implanted inside a patient's body andhaving a first open end portion connected to a surgically createdlateral opening in a wall of the patient's intestine. The second openend portion exits the patient's abdominal wall forming a stomy. Theartificial intestine section is here shown as a black box and mayinclude an artificial reservoir for intestinal contents, a motor, one ormore valves, a pump and/or any other flow control device.

The system shown in FIG. 136 corresponds to the one shown in FIG. 135,however, with the second open end portion of the artificial intestinesection exiting the patient's anus.

FIG. 137 shows a system where both the first and second open endportions of the artificial intestine section are attached to surgicallycreated lateral openings in a wall of the patient's small and/or largeintestine. The downstream part of the intestine exits the patient'sabdominal wall forming a surgically created stomy. The downstream partof the intestine may as well exit through the patient's anus.

FIG. 138 shows a similar system with the difference that the second openend portion is connected to a cross-sectional opening of the patient'sintestine, further leading to the surgically created stomy. Thedownstream part of the intestine may as well exit through the patient'sanus.

FIG. 139 shows the structure of the first open end portion of theartificial intestine section for attaching the artificial intestinesection to the lateral opening in the patient's intestine by means of ashoulder portion formed around the end portion. The end portion is sewnto the intestine and may additionally or alternatively be stapled and/orglued to the intestine.

FIG. 140 shows an improved structure for lateral attachment to theintestine, wherein the shoulder portion is split into an upper and alower shoulder portion forming a gap to accommodate intestinal walltissue therein. The surface area of the upper shoulder portion is largerthan the surface area of the lower shoulder portion.

FIG. 141 shows an enlarged view of a ring-and-bulge connection by whichthe artificial intestine section and the patient's downstream intestinalpart are connected, as shown in FIG. 138.

FIGS. 142A and 142B show the ring-and-bulge connection of FIG. 141 incombination with a sleeve. The sleeve is rolled upon itself and can beunrolled such that a part of the intestine is located intermediate thesleeve and the conduit. Thereafter, the ring is pushed over the sleeveagainst the bulge.

FIGS. 143A and 143B show a connection of the artificial intestinesection to the cross-sectional opening of the patient's intestinesimilar to the connection shown in FIGS. 142A and 142B, however, withoutthe bulge and the ring.

FIGS. 144A and 144B show an alternative to the connection in FIGS. 143Aand 143B. Instead of unrolling the sleeve, it is simply pulled over theintestine.

FIGS. 145A and 145B show another sleeve connection. Here, the sleeve ismounted on the outer surface of the open end portion so as to befoldable upon itself. By folding the flexible sleeve upon itself, a partof the intestine is located intermediate the folded sleeve.

FIG. 146 shows an embodiment of the artificial intestine section with anartificial reservoir and an entry valve and exit valve arranged upstreamand downstream of the reservoir. The reservoir is mounted with a pump ina common housing and the pump and the entry and exit valves arecontrolled by means of a control device, of which a part is implantedinside the patient's body. Data are transmitted wirelessly between theexternal part and implanted part of the control unit. In addition,energy is wirelessly transmitted to the artificial intestine section orto an accumulator also implanted in the patient's body and galvanicallyconnected here to the valves and pump.

FIGS. 147A and 147B show a first embodiment of the structure of FIG. 146in more detail. The pump comprises a moveable piston with a front end ofthe piston extending into the reservoir such that a volume of thereservoir is reduced upon advancement of the piston. The piston isspring loaded so as to urge the piston into a normally retractedposition. Furthermore, entry and exit valves are here realized as flapvalves. The flap valves are controlled so that one valve is open whilethe other one is closed.

FIGS. 148A and 148B show a system similar to the one of FIGS. 147A and147B. However, here the entry and exit valves comprise bellows acting onthe intestine from the outside so as to close the intestine bycompression. In FIG. 148A the bellows of the exit valve are expanded tocompress the artificial intestine section at the downstream side of thereservoir, whereas in FIG. 148B the artificial intestine section isclosed by means of the bellows of the entry valve upstream of thereservoir so that the reservoir can be emptied by advancing the pistonof the pump.

FIG. 149 shows an embodiment schematically, wherein the artificialintestine section by-passes a section of the patients intestine, theintestine being closed by sewing so as to direct intestinal contenttowards the artificial intestine section. An exit valve is provided forcontrolling the flow of intestinal contents from the artificialintestine section. The enlarged area of the artificial intestine sectionrepresents any kind of element acting on the intestinal contents withinthe artificial intestine section, such as a reservoir, one or morevalves, a pump or any other flow control device, possibly including amotor, and the like.

FIG. 150 shows a by-passing artificial intestine section in action,further leading to a surgically created stoma. A pump or valve may becontained in the artificial intestine section.

FIG. 151 shows the artificial intestine section of FIG. 150 with a largereservoir and an exit valve downstream the reservoir.

FIG. 152 shows the by-passing artificial intestine section including apump and a valve incorporated therein. Furthermore, a batteryimplantable in the patient's body and preferably rechargeable providesthe artificial intestine section with energy. The artificial intestinesection is wirelessly controlled and the battery, if rechargeable,wirelessly charged. A sensor implanted on or within the intestinedelivers data on the physical conditions within the intestine forcontrolling the artificial intestine section.

FIGS. 153A to 153C show an embodiment, where the artificial intestinesection comprises a reservoir with a flexible wall. A pump is implantedin the patient's body separate but in close proximity to the reservoirand is used to empty the reservoir. The pump is actuated by means of asubcutaneously implanted, manually operable switch.

FIGS. 153D and 153E show a structure similar to the one of FIGS. 153A to153C, however, with the pump and the reservoir being fixedly connectedto one another. The reservoir is formed by a bellow having an end wallclosing the bellow at one end thereof. The end wall makes part of thepump such that a volume of the bellow can be reduced upon advancement ofthe end wall. The bellow is made of a resilient material so as to urgethe bellow into a normally extended position

FIGS. 154A and 154B show a variant to FIGS. 153D and 153E.

Here, the pump and reservoir are integrally combined. The pump ismanually operable and subcutaneously mounted so as to be operable fromthe outside of the patient's body.

FIGS. 155A and 155B likewise show a variant to the system shown in FIGS.153D and 153E. While in the system of FIGS. 153D, 153E the pump isautomatically driven, such as by an integrated motor, and activated viaremote control, the system in FIGS. 155A and 155B is again manuallyoperable in that the manually operable pump is mounted subcutaneously.

FIGS. 160A to 160C show a plurality of cooperating valves implantedinside the patient's body and outside the patient's intestine. These canbe positioned behind and/or in front of the artificial intestine piecealong the patient's natural intestine. Each of the valves comprises anelectrical stimulation device adapted to electrically stimulate muscleor neural tissue of an intestine section so as to cause at least partialcontraction of the intestine section. For that purpose, the stimulationdevice comprises at least one electrode adapted to apply electric pulsesto the intestine section. While instead of the three stimulation devicesshown, a single stimulation device would be sufficient for opening andclosing the intestine, the arrangement of the plurality of stimulationdevices is adapted to stimulate different portions of the intestinesection over time. The function of the three stimulation devices mayalso be combined in one integral unit. The direction of naturalintestinal contents flow is indicated by arrows. The different portionsof the intestine section in a wavelike manner may be made in a directionopposite to the natural intestinal contents flow, as shown in FIGS. 160Ato 160C, so as to close the intestine section. The stimulation in thewavelike manner may also be made in the direction of natural intestinalcontents flow to support emptying of the intestine or reservoir.

FIGS. 161A to 161C show the stimulation devices of FIGS. 160A to 160C incombination with constriction devices, such as the bellow valvesdescribed in relation to FIGS. 148A and 148B, for at least partlyconstricting the intestine section mechanically. Complete constrictionis obtained by additional electrical stimulation of the respectiveintestine sections. The constriction devices may be released in order toallow intestinal contents to flow through.

FIG. 162 shows a system similar to the system of FIG. 135, however, witha flow control device in the form of an exit valve being implantedwithin the artificial intestine section. An external manually drivensuction pump is used for emptying the artificial intestine section,wherein a conduit on the front end of the pump is inserted from outsidethe patients body into the intestine, thereby mechanically urging theexit valve to open.

FIGS. 163A and 163B schematically illustrate different stages ofoperation of a general apparatus according to the present invention,wherein a pump of the apparatus is applied on a patient's intestines.

FIGS. 164A and 164B schematically illustrate different stages ofoperation of the general apparatus of FIGS. 163A and 163B also includingan electric stimulation device.

FIGS. 165A, 165B and 165C schematically illustrate different stages ofoperation of an embodiment of the present invention, wherein aperistaltic pump is applied on a patient's intestines.

FIGS. 166A, 166B and 166C schematically illustrate the embodiment ofFIGS. 165A-165C also including an electric stimulation device.

FIGS. 167A, 167B and 167C are longitudinal cross-sections of anembodiment of the invention showing different stages of operation,wherein a pump includes a constriction device that radially constricts apatient's intestines.

FIGS. 168A, 168B and 168C are longitudinal cross-sections of amodification of the embodiment of FIGS. 167A-167C, including an electricstimulation device.

FIG. 169 shows the same embodiment as that of FIG. 168C illustrating amodified operation of the stimulation device.

FIG. 170 shows the embodiment of FIG. 168A when the pump is not inoperation.

FIGS. 171A, 171B, 171C and 171D illustrate a modified operation of thestimulation device of the embodiment according to FIG. 168A when thepump is not in operation.

FIGS. 172A, 172B and 172C are longitudinal cross-sections of anotherembodiment of the invention including an electric stimulation device andshowing different stages of operation.

FIGS. 173A and 173B are views of another embodiment of the inventionshowing different stages of operation, wherein a rotary peristaltic pumpis applied on a patient's small intestines.

FIGS. 174A and 174B are views of a modification of the embodiment ofFIGS. 173A and 173B, also including an electric stimulation device.

FIGS. 175A through 175D are longitudinal cross-sections of anotherembodiment of the invention showing different stages of operation,wherein another type of peristaltic pump is applied on a patient's smallintestines.

FIGS. 176A through 176D are longitudinal cross-sections of amodification of the embodiment of FIGS. 175A-175D, including an electricstimulation device.

FIGS. 177A and 177B show different stages of operation of anotherembodiment of the invention including a separate intestinal closure.

FIG. 178A shows another embodiment of the invention including anartificial intestinal piece implanted in a colostomy patient, wherein apump operates on the artificial intestinal piece.

FIG. 178B shows the artificial intestinal piece of FIG. 178A joined tothe patient's anus.

FIG. 179 shows an enlarged detail of the embodiment of FIG. 178.

FIG. 180 shows a modification of the embodiment of FIG. 179.

FIGS. 181A, 181B, 181C and 181D schematically illustrate differentstages of operation of another embodiment of the invention, wherein apump includes a constriction device that axially constricts a patient'sIntestines.

FIG. 181E illustrates the embodiment of FIG. 181D also including anelectric stimulation device.

FIG. 182 is a side view of another embodiment of the invention, whereina pump includes a hydraulically operable constriction device applied ona patient's intestines in a first stage of operation.

FIGS. 183 and 184 are views taken along section lines XXII-XXII andXXIII-XXIII, respectively, in FIG. 182.

FIG. 185 is a side view of the embodiment of FIG. 182 with theconstriction device in a second stage of operation.

FIGS. 186 and 187 are views taken along section lines XXV-XXV andXXVI-XXVI, respectively, in FIG. 185.

FIGS. 188A and 188B show different stages of operation of a hydraulicreverse servo suited for connection with the hydraulic constrictiondevice of FIGS. 182-187.

FIGS. 189A and 189B show different stages of operation of a mechanicallyoperated constriction device suited for use in some of the embodimentsof the present invention.

FIG. 189C is a modification of the embodiment of FIGS. 189A and 189B.

FIG. 190 illustrates the pump of the embodiment of FIGS. 168A and 168Bapplied on the small intestines of a colostomy patient.

FIG. 191 illustrates the pump of the embodiment of FIGS. 168A and 168Bapplied on a colostomy patient's small intestines ending at thepatient's anus.

FIG. 192A shows a surgically modified section of a human intestineforming an intestinal reservoir with a deactivated entry valve in frontand an activated exit valve behind the intestinal reservoir.

FIG. 192B shows the intestinal reservoir of FIG. 192A with the entryvalve activated and the exit valve deactivated.

FIG. 193A shows a plan view of an electrical type pump for emptying theintestinal reservoir of FIG. 192B with a plurality of rod-likeelectrical stimulation devices placed side by side adjacent theintestinal reservoir.

FIG. 193B shows a side view of the electrical type pump of FIG. 193A.

FIG. 194A shows a side view of a variant of the electrical type pump ofFIG. 193B with the plurality of rod-like electrical stimulation devicesplaced side by side in folds formed by the wall of the intestinalreservoir.

FIG. 194B shows the variant of the electrical type pump of FIG. 194A ina different, cross-sectional side view.

FIG. 195A shows a plan view of a mechanical type pump for emptying theintestinal reservoir of FIG. 192B.

FIG. 195B shows a side view of the mechanical type pump of FIG. 195A.

FIG. 196A shows a plan view of a hydraulic type pump for emptying theintestinal reservoir of FIG. 192B.

FIG. 1968 shows a side view of the hydraulic type pump of FIG. 196A.

FIG. 197A shows a surgically modified section of a human intestineforming an intestinal reservoir with a deactivated entry valve in frontand an activated exit valve behind the intestinal reservoir.

FIG. 197B shows the intestinal reservoir of FIG. 197A with the entryvalve activated and the exit valve deactivated.

FIG. 198A shows a plan view of an electrical type pump for emptying theintestinal reservoir of FIG. 197B with a plurality of rod-likeelectrical stimulation devices placed side by side adjacent theintestinal reservoir.

FIG. 198B shows a side view of the electrical type pump of FIG. 198A.

FIG. 199A shows a side view of a variant of the electrical type pump ofFIG. 198B with the plurality of rod-like electrical stimulation devicesplaced side by side in folds formed by the wall of the intestinalreservoir.

FIG. 199B shows the variant of the electrical type pump of FIG. 199A ina different, cross-sectional side view.

FIG. 200A shows a plan view of a mechanical type pump for emptying theintestinal reservoir of FIG. 197B.

FIG. 200B shows a side view of the mechanical type pump of FIG. 200A.

FIG. 201A shows a plan view of a hydraulic type pump for emptying theintestinal reservoir of FIG. 197B.

FIG. 201B shows a side view of the hydraulic type pump of FIG. 201A.

FIG. 202 shows an examplary view of a patient with one tissue connectorconnected to the patient's aorta and another tissue connector connectedto the end of the patient's large bowel.

FIGS. 203a and 203b show a cross-section of a first embodiment of thetissue connector in the state of mounting and in the connected state.

FIGS. 204a and 204b show a cross-section of an alternative of the firstembodiment of the tissue connector in the state of mounting and in theconnected state.

FIGS. 205 and 206 show a second embodiment of the tissue connector inthe state of mounting and in the connected state.

FIG. 207 shows an alternative for mounting living tissue on a free endof the tissue connector.

FIGS. 208a and 208b show a combination of an embodiment similar to theone shown in FIGS. 203a and 203b with additional mounting means as shownin FIG. 207.

FIG. 209 shows a specific embodiment of a tissue connector with two endsthereof connected to living tissue.

FIG. 210 shows an examplary view of a patient with one tissue connectorconnected to the patient's aorta and another tissue connector connectedto the end of the patient's large bowel.

FIG. 211 shows a cross section of a first embodiment of the tissueconnector in a state connected to living tissue.

FIG. 212 shows a second embodiment of the tissue connector with twoconnecting ends.

FIG. 213 shows a third embodiment of the tissue connector as analternative to the second embodiment.

FIGS. 214a and 214b show an alternative for mounting living tissue on afree end of the tissue connector.

FIGS. 215a and 215b show another alternative for mounting living tissueon a free end of the tissue connector.

FIGS. 216a and 216b show a further alternative for mounting livingtissue on a free end of the tissue connector.

FIGS. 217a and 217b show a combination of an embodiment similar to theone shown in FIG. 211 with additional mounting means as shown in FIGS.214a and 214 b.

FIG. 218 is general view of a human body having a device for treatinganeurysm implanted.

FIG. 219 is a view illustrating a device for treating aneurysm withassociated equipment.

FIG. 220 is a view illustrating a mechanical device for treatinganeurysm.

FIG. 221 is a view illustrating a mechanical device for treatinganeurysm.

FIG. 222 is a view illustrating a hydraulic device for treatinganeurysm.

FIG. 223 is a view illustrating a hydraulic device for treatinganeurysm.

FIG. 224 is a view illustrating a hydraulic device for treatinganeurysm.

FIG. 225 is a view illustrating a stimulation device for treating avascular aneurysm of a human or mammal patient.

FIG. 226 is a view illustrating a sensor used when treating ormonitoring a vascular aneurysm of a human or mammal patient.

FIG. 227 is a view from above of a device for treating aneurysmimplanted around a blood vessel.

FIG. 228 is a view of a device for treating aneurysm having a Y-shape.

FIG. 229 is a flowchart illustrating steps performed when implanting adevice for treating or monitoring an aneurysm in accordance with oneembodiment.

FIG. 230 is a flowchart illustrating steps performed when implanting adevice for treating or monitoring an aneurysm in accordance with oneembodiment.

FIG. 231 is a flowchart illustrating steps performed when implanting adevice for treating or monitoring an aneurysm in accordance with oneembodiment.

FIG. 232 is a flowchart illustrating steps performed when implanting adevice for treating or monitoring an aneurysm in accordance with oneembodiment.

FIG. 233 illustrates a system for treating a disease, wherein the systemincludes a device of the invention implanted in a patient

FIG. 234-248 schematically show various embodiments of the system forwirelessly powering the device shown in FIG. 233.

FIG. 249 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of thedevice shown in FIG. 233.

FIG. 250 schematically shows an embodiment of the system, in which thedevice is operated with wire bound energy.

FIG. 251 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the device shown in FIG. 233.

FIG. 252 is a circuit for the arrangement shown in FIG. 251, accordingto a possible implementation example.

FIGS. 253-259C show various ways of arranging hydraulic or pneumaticpowering of a device implanted in a patient.

DETAILED DESCRIPTION OF THE INVENTION

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures. Inthe following text, the term “organ” includes (but is not limited to)the esophagus, stomach, intestines, urine bladder, urethra, ureter,renal pelvis, blood vessels, aorta, corpus cavernosum, exit veins oferectile tissue, uterine tube, vas deference and bile duct.

FIGS. 1A, 1B and 1C schematically illustrate different states ofoperation of a generally designed apparatus according to the presentinvention, when the apparatus is applied on a wall portion of a bodilyorgan designated BO. The apparatus includes a constriction device and astimulation device, which are designated CSD, and a control devicedesignated CD for controlling the constriction and stimulation devicesCSD. FIG. 1A shows the apparatus in an inactivation state, in which theconstriction device does not constrict the organ BO and the stimulationdevice does not stimulate the organ BO. FIG. 1B shows the apparatus in aconstriction state, in which the control device CD controls theconstriction device to gently constrict the wall portion of the organ BOto a constricted state, in which the blood circulation in theconstricted wall portion is substantially unrestricted and the flow inthe lumen of the wall portion is restricted. FIG. 1C shows the apparatusin a stimulation state, in which the control device CD controls thestimulation device to stimulate different areas of the constricted wallportion, so that almost the entire wall portion of the organ BOcontracts (thickens) and closes the lumen.

FIGS. 1D and 1E show how the stimulation of the constricted wall portioncan be cyclically varied between a first stimulation mode, in which theleft area of the wall portion (see FIG. 1D) is stimulated, while theright area of the wall portion is not stimulated, and a secondstimulation mode, in which the right area of the wall portion (see FIG.1E) is stimulated, while the left area of the wall portion is notstimulated, in order to maintain over time satisfactory bloodcirculation in the constricted wall portion.

It should be noted that the stimulation modes shown in FIGS. 1D and 1Eonly constitute a principle example of how the constricted wall portionof the organ BO may be stimulated. Thus, more than two different areasof the constricted wall portion may be simultaneously stimulated incycles or successively stimulated. Also, groups of different areas ofthe constricted wall portion may be successively stimulated.

FIGS. 1F, 1G and 1H illustrate different states of operation of amodification of the general embodiment shown in FIGS. 1A-1E, wherein theconstriction and stimulation devices CSD include several separateconstriction/stimulation elements, here three elements CSDE1, CSDE2 andCSDE3. FIG. 1F shows how the element CSDE1 in a first state of operationis activated to both constrict and stimulate the organ BO, so that thelumen of the organ BO is closed, whereas the other two elements CSDE2and CSDE3 are inactivated. FIG. 1G shows how the element CSDE2 in asecond following state of operation is activated, so that the lumen ofthe organ BO is closed, whereas the other two elements CSDE1 and CSDE3are inactivated. FIG. 1H shows how the element CSDE3 in a followingthird state of operation is activated, so that the lumen of the organ BOis closed, whereas the other two elements CSDE1 and CSDE2 areinactivated. By shifting between the first, second and third states ofoperation, either randomly or in accordance with a predeterminedsequence, different portions of the organ can by temporarily constrictedand stimulated while maintaining the lumen of the organ closed, wherebythe risk of injuring the organ is minimized. It is also possible toactivate the elements CSDE1-CSDE3 successively along the lumen of theorgan to move fluids and/or other bodily matter in the lumen.

FIGS. 1I, 1K and 1L illustrate an alternative mode of operation of themodification of the general embodiment. Thus, FIG. 11 shows how theelement CSDE1 in a first state of operation is activated to bothconstrict and stimulate the organ BO, so that the lumen of the organ BOis closed, whereas the other two elements CSDE2 and CSDE3 are activatedto constrict but not stimulate the organ BO, so that the lumen of theorgan BO is not completely closed where the elements CSDE2 and CSDE3engage the organ BO. FIG. 1K shows how the element CSDE2 in a secondfollowing state of operation is activated to both constrict andstimulate the organ BO, so that the lumen of the organ BO is closed,whereas the other two elements CSDE1 and CSDE3 are activated toconstrict but not stimulate the organ BO, so that the lumen of the organBO is not completely closed where the elements CSDE1 and CSDE3 engagethe organ BO. FIG. 1L shows how the element CSDE3 in a following thirdstate of operation is activated to both constrict and stimulate theorgan BO, so that the lumen of the organ BO is closed, whereas the othertwo elements CSDE1 and CSDE2 are activated to constrict but notstimulate the organ BO, so that the lumen of the organ BO is notcompletely closed where the elements CSDE1 and CSDE2 engage the organBO. By shifting between the first, second and third states of operation,either randomly or in accordance with a predetermined sequence,different portions of the organ can by temporarily stimulated whilemaintaining the lumen of the organ closed, whereby the risk of injuringthe organ is reduced. It is also possible to activate the stimulation ofthe elements CSDE1-CSDE3 successively along the lumen of the organ BO tomove fluids and/or other bodily matter in the lumen.

FIGS. 2-4 show basic components of an embodiment of the apparatusaccording to the invention for controlling a flow of fluid and/or otherbodily matter in a lumen formed by a tissue wall of a patient's organ.The apparatus comprises a tubular housing 1 with open ends, aconstriction device 2 arranged in the housing 1, a stimulation device 3integrated in the constriction device 2, and a control device 4(indicated in FIG. 4) for controlling the constriction and stimulationdevices 2 and 3. The constriction device 2 has two elongate clampingelements 5, 6, which are radially movable in the tubular housing 1towards and away from each other between retracted positions, see FIG.3, and clamping positions, see FIG. 4. The stimulation device 3 includesa multiplicity of electrical elements 7 positioned on the clampingelements 5, 6, so that the electrical elements 7 on one of the clampingelements 5, 6 face the electrical elements 7 on the other clampingelement. Thus, in this embodiment the constriction and stimulationdevices form a constriction/stimulation unit, in which the constrictionand stimulation devices are integrated in a single piece.

The constriction and stimulation devices may also be separate from eachother. In this case, a structure may be provided for holding theelectrical elements 7 in a fixed orientation relative to one another.Alternatively, the electrical elements 7 may include electrodes that areseparately attached to the wall portion of the patient's organ.

FIGS. 5A-5C illustrate in principle the function of the apparatus ofFIG. 2 when the apparatus is applied on a portion 8 of a tubular tissuewall of a patient's organ. Thus, FIG. 5A shows the apparatus in anon-clamping state, in which the clamping elements 5, 6 are in theirretracted positions and the wall portion 8 extends through the open endsof the housing 1 without being constricted by the clamping elements 5,6. FIG. 5B shows the apparatus in a clamping state, in which theclamping elements 5, 6 have been moved from their retracted positions totheir clamping positions, in which the clamping elements 5, 6 gentlyconstrict the wall portion 8 to a constricted state, in which the bloodcirculation in the constricted wall portion 8 is substantiallyunrestricted and the flow in the lumen of the wall portion 8 isrestricted. FIG. 5C shows the apparatus in a stimulation state, in whichthe clamping elements 5, 6 constrict the wall portion 8 and theelectrical elements 7 of the stimulation device 3 electrically stimulatedifferent areas of the wall portion 8, so that the wall portion 8contracts (thickens) and closes the lumen.

When the apparatus is in its stimulation state, it is important tostimulate the different areas of the wall portion 8 in a manner so thatthey essentially maintains their natural physical properties over timeto prevent the areas from being injured. Consequently, the controldevice 4 controls the stimulation device 3 to intermittently stimulateeach area of the wall portion 8 during successive time periods, whereineach time period is short enough to maintain over time satisfactoryblood circulation in the area. Furthermore, the control device 4controls the stimulation of the areas of the wall portion 8, so thateach area that currently is not stimulated restores substantially normalblood circulation before it is stimulated again. To maintain over timethe effect of stimulation, i.e., to keep the lumen closed by maintainingthe wall portion 8 contracted, the control device 4 controls thestimulation device 3 to stimulate one or more of the areas at a time andto shift the stimulation from one area to another over time. The controldevice 4 may control the stimulation device 3 to cyclically propagatethe stimulation of the areas along the tubular wall portion 8, forexample, in accordance with a determined stimulation pattern. To achievethe desired reaction of the tissue wall during the stimulation thereof,the control device may control the stimulation device to, preferablycyclically, vary the intensity of the stimulation of the wall portion 8.

In the embodiment of FIGS. 2-4, the electrical elements 7 form a seriesof fourteen groups of electrical elements 7 extending longitudinallyalong each elongate clamping element 5 and 6, respectively, see FIG. 2.The electrical elements 7 of each group of electrical elements 7 form afirst path of four electrical elements 7 positioned in a row on clampingelement 5 and extending tranverse thereto, and a second path of fourelectrical elements 7 positioned in a row on clamping element 6 andextending tranverse thereto. Thus, the two paths of electrical elements7 extend on mutual sides of the patient's organ. The control device 4controls the stimulation device 3 to successively energize the groups ofelectrical elements 7 in the series of groups in a direction opposite toor, alternatively, in the same direction as that of the flow in thelumen of the patient's organ. Of course, the number of electricalelements 7 of each path of electrical elements 7 can be greater orsmaller than four, and several parallel rows electrical elements 7 canform each path of electrical elements 7.

FIGS. 6A-6C show another embodiment of the invention which includes atubular housing 9 and three elongate clamping elements 10 a, 10 b, 10 c,which are radially movable in the tubular housing 9 towards and awayfrom a central axis thereof between retracted positions, see FIG. 6A,and clamping positions, see FIG. 6B. The three clamping elements 10 a-10c are symmetrically disposed around the central axis of the housing 9.The stimulation device of this embodiment includes electrical elements11 a, 11 b, 11 c that form a series of groups of elements extendinglongitudinally along the elongate clamping elements 10 a-10 c, whereinthe electrical elements 11 a-11 c of each group of electrical elementsform a path of three electrical elements 11 a, 11 b and 11 c extendingcircumferentially around the central axis of the housing 9. The threeelectrical elements 11 a-11 c of each group are positioned on the threeclamping elements 10 a-10 c, respectively. Thus, the path of threeelectrical elements 11 a-11 c extends around the patient's organ. Ofcourse, the number of electrical elements 11 a-11 c of each path ofelectrical elements can be greater than three, and several parallel rowselectrical elements 11 a-11 c can form each path of electrical elements.

FIGS. 7A and 7B show different steps of an electric stimulation modeperformed by the apparatus of FIG. 2 while the clamping elements 5, 6 ofthe apparatus are constricting a portion of a tubular tissue wall of apatient's organ 12 to restrict the flow in the lumen 13 of the organ 12.For the sake of clarity only the clamping elements 5, 6 of theconstriction device 2 are shown in FIGS. 7A, 7B. Thus, FIG. 7Aillustrates how energized electrical elements 7 of groups of electricalelements electrically stimulate a first portion 14 and a second portion15 of the tubular wall to contract and close the lumen 13. FIG. 78Billustrates how energized electrical elements 7 of other groups ofelectrical elements electrically stimulate a third portion 16 of thetubular wall different from the first and second portions to contractand close the lumen 13, while the electrical stimulation of the firstand second portions 14, 15 of the tubular wall has been ceased, so thatsubstantially normal blood circulation in the first and second portionsis restored. In this manner, the electric stimulation of the constrictedtubular wall is shifted over time from one portion of the tubular wallto another to insure recurrent restoration of blood circulation in theconstricted tubular wall.

The control device 4 controls the stimulation device 3 to energize theelectrical elements 7 with electric biphasic pulses, i.e., combinedpositive and negative pulses. The desired stimulation effect is achievedby varying different pulse parameters. Thus, the control device 4controls the stimulation device 3 to vary the pulse amplitude (voltage),the off time period between successive pulses, the pulse duration andthe pulse repetition frequency. The pulse current should be between 1 to30 mA. For neural stimulation, a pulse current of about 5 mA and a pulseduration of about 300 μs are suitable, whereas a pulse current of about20 mA and a pulse duration of about 30 μs are suitable for muscularstimulation. The pulse repetition frequency suitably is about 10 Hz. Forexample, as illustrated in the Pulse/time diagram P/t of FIG. 8A, apulse combination including a negative pulse PS of short duration andhigh amplitude (voltage), and a positive pulse PL of long duration andlow amplitude following the negative pulse may be cyclically repeated toform a pulse train of such pulse combinations. The energy content of thenegative pulse PS should be substantially equal to the energy content ofthe positive pulse PL.

FIG. 8B is a pulse/time diagram showing a modification of the electricstimulation shown in FIG. 8A. Thus, the pulse combination of FIG. 8A ismixed with a pulse train combination having a first relatively longpulse train PTL of high frequency/low amplitude pulses, appearingsimultaneously with the positive pulse PL of the pulse combination ofFIG. 8A, and a second relatively short pulse train PTS of highfrequency/low amplitude appearing simultaneously with the negative pulsePS of the pulse combination shown in FIG. 8A. As a result, the highfrequency/low amplitudes pulse trains PTL and PTS are superimposed onthe positive and negative pulses PL and PS of FIG. 8A, as illustrated inFIG. 8B. The pulse configuration of FIG. 8B, and variations thereof, isbeneficial to use in connection with the stimulation of particular humanorgans, in order to achieve the desired stimulation effect.

Preferably, the electric pulses form pulse trains, as Illustrated in thePulse/time diagrams P/t of FIGS. 9A, 9B, 9C and 9D. The Pulse/timediagram P/t of FIG. 9A represents an individual area of the wall portionof the patients tubular organ which is stimulated with a pulse train18A. The pulse train 18A includes three initial negative pulses, each ofwhich is of short duration and high amplitude (voltage), and onepositive pulse of long duration and low amplitude following the negativepulses. After a delay to enable the area of the organ to restoresubstantially normal blood circulation, the pulse train 18A is repeated.

The Pulse/time diagram PA of FIG. 9B represents another individual areaof the wall portion, which is stimulated with a pulse train 18B havingthe same configuration as the pulse train 18A. The pulse trains 18A and18B are shifted relative to each other, so that they partially overlapone another to ensure that the constricted wall portion always isstimulated to contract as desired.

The pulse/time diagrams P/t of FIGS. 10A and 10B represent two differentareas of the wall portion, which are stimulated with cyclically repeatedpulse trains 18C and 18D, respectively, having the same configuration.Each pulse train 18C, 18D includes two initial negative pulses, each ofwhich is of short duration and high amplitude (voltage), and onepositive pulse of long duration and low amplitude following the twonegative pulses. In this case, the pulse trains 18C and 18D are shiftedrelative to each other, so that they do not overlap each other. Thus,the off time period between adjacent pulse trains 18C is longer than theduration of pulse train 18D and the off time period between adjacentpulse trains 18D is longer than the duration of pulse train 18C.

The pulse trains 18A, 18B, 18C and 18D can be configured in manydifferent ways. Thus, the control device 4 can control the stimulationdevice 2 to vary the length of each pulse train, the repetitionfrequency of the pulse trains, the number of pulses of each pulse train,and/or the off time periods between the pulse trains. Typically, thecontrol device 4 controls each off time period between the pulse trainsto last long enough to restore substantially normal blood circulation inthe area that just has been stimulated before that area again isstimulated with electric pulses.

FIGS. 11A and 11B show another embodiment of the invention that controlsblood flow in a blood vessel 19, comprising a constriction device withtwo clamping elements 20 a and 20 b, a stimulation device in the form oftwo thermal stimulation elements 21 a and 21 b integrated in theclamping elements 20 a, 20 b, respectively, and a control device 4 forcontrolling the clamping elements 20 a, 20 b and stimulation elements 21a, 21 b. The clamping elements 20 a and 20 b are movable towards andaway from each other in the same manner as described above in connectionwith the embodiment according to FIGS. 5A-5C. The thermal stimulationelements 21 a and 21 b, which may include Pertier elements, arepositioned on the clamping elements 20 a, 20 b, so that the thermalelements 21 a are facing the thermal elements 21 b. FIG. 11A shows howthe clamping elements 20 a, 20 b constrict the blood vessel 19, so thatthe blood flow is restricted. FIG. 11B shows how the control device 4controls the thermal stimulation elements 21 a, 21 b to cool the wall ofthe blood vessel 19, so that the wall contracts and closes the bloodvessel 19. To release the blood vessel 19, the control device 4 controlsthe thermal stimulation elements 21 a. 21 b to heat the wall of theblood vessel 19, so that the wall expands.

FIGS. 12A and 12B show hydraulic operation means suited for operatingthe constriction device of the embodiments described above.Specifically, FIGS. 12A and 12B show the apparatus of FIG. 2 providedwith such means for hydraulic operation of the constriction device 2.(The stimulation device is not shown.) Thus, the housing 1 forms twohydraulic chambers 22 a and 22 b, in which the two clamping elements 5,6 are slidable back and forth relative to the tubular tissue wallportion 8 of a patient's organ. The hydraulic operation means include anexpandable reservoir 23, such as an elastic balloon, containinghydraulic fluid, conduits 24 a and 24 b between the reservoir 23 and thehydraulic chambers 22 a, 22 b, and a two-way pump 25 for pumping thehydraulic fluid in the conduits 24 a, 24 b. The control device 4controls the pump 25 to pump hydraulic fluid from the reservoir 23 tothe chambers 22 a, 22 b to move the clamping elements 5, 6 against thewall portion 8, whereby the tubular wall portion 8 is constricted, seeFIG. 12B, and to pump hydraulic fluid from the chambers 22 a, 22 b tothe reservoir 23 to move the clamping elements 5, 6 away from the wallportion 8, whereby the tubular wall 8 is released, see FIG. 12A.

Alternatively, the embodiment of FIGS. 12A and 12B may be manuallyoperated by applying suitable manually operable hydraulic means fordistributing the hydraulic fluid between the expandable reservoir 23 andthe hydraulic chambers 22 a, 22 b. In this case the pump 25 is omitted.

FIGS. 13A and 13B schematically show a mechanically operable embodimentof the invention, comprising an open ended tubular housing 26 applied onthe tubular tissue wall portion 8 of a patient's organ, a constrictiondevice 27 arranged in the housing 26 and a control device 4 forcontrolling the constriction device 27. A stimulation device (not shown)as described above is also provided in the housing 26. The constrictiondevice 27 includes a clamping element 28, which is radially movable inthe tubular housing 26 towards and away from the tubular wall portion 8between a retracted position, see FIG. 13A, and a clamping position, seeFIG. 13B, in which the clamping element 28 gently constricts the tubularwall portion 8. Mechanical operation means for mechanically operatingthe clamping element 28 includes an electric motor 29 attached to thehousing 26 and a telescopic device 30, which is driven by the motor 29and operatively connected to the clamping element 28. The control device4 controls the electric motor 29 to expand the telescopic device 30 tomove the clamping element 28 against the wall portion 8, whereby thetubular wall portion 8 is constricted, see FIG. 13B, and controls themotor 29 to retract the telescopic device 30 to move the clampingelement 28 away from the wall portion 8, whereby the wall portion 8 isreleased, see FIG. 13A.

Alternatively, the motor 29 may be omitted and the telescopic device 30be modified for manual operation, as shown in FIG. 13C. Thus, a spring30 a may be provided acting to keep the telescopic device 30 expanded toforce the clamping element 28 against the wall portion 8. The mechanicaloperation means may include a subcutaneously implanted lever mechanism29 a that is operatively connected to the telescopic device 30. Thepatient may push the lever mechanism 29 a through the patient's skin 29b to pull the telescopic device 30 against the action of the spring 30 ato the retracted position of the telescopic device 30, as indicated inphantom lines. When the patient releases the lever mechanism 29 a, thespring 30 a expands the telescopic device 30, whereby clamping element28 is forced against the wall portion 8.

The mechanical operation means as described above in connection withFIGS. 13A, 13B and 13C may also be implemented in the embodimentsaccording to FIGS. 1-11.

FIG. 14A illustrates the embodiment of FIG. 2 applied on the smallintestines 31 of a colostomy patient having a stoma in the abdomen. Theclamping elements 5, 6 of the constriction device 2 constrict the smallIntestines 31 and the stimulation device 3 is energized to close theintestinal passageway. (For the sake of clarity, the housing is notshown and the clamping elements 5, 6 are exaggerated.) In thisembodiment, a control device includes an external control unit in theform of a hand-held wireless remote control 32, and an implantedinternal control unit 33, which may include a microprocessor, forcontrolling the constriction and stimulation devices. The remote control32 is operable by the patient to control the internal control unit 33 toswitch on and off the constriction device and/or the stimulation device.Alternatively, however, the remote control 32 may be replaced by asubcutaneously implanted push button that is manually switched by thepatient between “on” and“off”. Such a manually operable push button mayalso be provided in combination with the remote control 32 as anemergency button to allow the patient to stop the operation of theapparatus in case of emergency or malfunction.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, also works as en energy receiver, i.e., for transformingwireless energy into electric energy and charging the implanted sourceof energy 35 (rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the pressure in the intestines, or a parameter that relates to thepressure in the intestines, wherein the internal control unit 33controls the constriction device 2 and/or the stimulation device 3 inresponse to signals from the sensor 36. In this embodiment the sensor 36is a pressure sensor, wherein the internal control unit 33 controls theconstriction device and/or stimulation device to change the constrictionof the patient's intestines 31 in response to the pressure sensor 36sensing a predetermined value of measured pressure. For example, thecontrol unit 33 may control the constriction device and/or stimulationdevice to increase the constriction of the patient's intestines 31 inresponse to the pressure sensor sensing an increased pressure.Alternatively or in combination, the remote control 32 controls theconstriction device and/or stimulation device in response to signalsfrom the sensor 36, in the same manner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36. When the patient's attention is taken bysuch an indication indicating an increased pressure exceeding athreshold value, he or she may use the remote control to control theconstriction device and stimulation device to pump intestinal contentsthrough the patient's stoma.

FIG. 14B shows an embodiment which is similar to the embodiment of FIG.14A except that the constriction device is applied on the smallintestines of a colostomy patient having the small intestines surgicallyconnected to the patient's anus.

Of course, the constriction device 2 shown in FIGS. 14A and 14B may bereplaced by any one of the constriction devices described in the variousembodiments of the present invention, where applicable.

FIGS. 15-17 show a mechanically operable constriction device having anelongated constriction member in the form of a circular resilient core37 with two overlapping end portions 38, 39. The core 37 defines asubstantially circular restriction opening and is enclosed in an elasticsoft hose 40 except at a releasable and lockable joint 41 of the core37, which when released enables application of the core 37 with its hose40 around a portion of a tubular tissue wall of a patient's organ. Thematerials of all of these elements are bio-compatible so that thepatient' body will not reject them. An operation device 42 formechanically operating the longitudinal extension of the core 37 tochange the size of the restriction opening comprises a drive wheel 43 infrictional engagement with the overlapping end portions 38, 39 of thecore 37. The drive wheel 43 is journalled on a holder 44 placed in thehose 40 and provided with two counter pressure rollers 45, 46 pressingthe respective end portions 38, 39 of the core 37 against the drivewheel 43 to increase the frictional engagement there between. Anelectric motor 47 of the operation device is connected to the drivewheel 43 via a long flexible drive shaft 48, and is moulded togetherwith a remote controlled power supply unit 49 in a body 50 of siliconerubber. The length of the flexible drive shaft 48 is selected so thatthe body 50 can be placed in a desired position in the patient's body,suitably in the abdomen.

The power supply unit 49 can be controlled to power the electric motor47 to turn the drive wheel 43 in one direction to reduce the diameter ofthe core 37, so that the wall portion is constricted, or to turn thedrive wheel 43 in the opposite direction to increase the diameter of thecore 37, so that the wall portion is released.

In accordance with a first alternative, a rack gear may be formed on oneof the end portions 38, 39 of the core 37 and the drive wheel 43 may bereplaced by a drive gear wheel connected to the other end portion of thecore 37 and in mesh with the rack gear.

In accordance with a second alternative, the operation device 42 may bedesigned as a worm-driven hose clamp, i. e., one of the end portions 38,39 of the core 37 may be provided with threads and the other end portionof the core 37 may be provided with a worm, the threads of whichinteracts with the threads of said one end portion of the core 37. Thethreads of such a worm may also interact with threads provided on bothend portions 38, 39 of the core 37. In this alternative, the electricmotor 47 turns the worm in one direction to reduce the diameter of thecore 37, so that the wall portion is constricted, or turn the worm inthe opposite direction to increase the diameter of the core 37, so thatthe wall portion is released in one direction to reduce the diameter ofthe core 37, so that the wall portion is constricted, or turns theclamping screw in the opposite direction to increase the diameter of thecore 37, so that the wall portion is released.

FIG. 18 shows a constriction device which is identical to the embodimentof FIGS. 15-17, except that the motor 47 is encapsulated in the hose 40so that it is fixed to the core 37 and has a short drive shaft 51, andthat the motor 47 is positioned relative to the core 37, such that thedrive shaft 51 extends substantially tangentially to the circular core37. There is an angular gearing 52 connecting the drive shaft 51 to thedrive wheel 43.

FIG. 19 shows a suitable alternative arrangement for the motor 47 in theembodiment of FIG. 18, comprising a first clamping member 53 secured toone end portion of the core 37 and a second clamping member 54 securedto the other end portion 39 of the core 37. The motor 47 is secured tothe first clamping member 53 and is operatively connected to a worm gear55 via a gear transmission 56. The worm gear 55 is journelled at itsopposite ends on holders 57 and 58, which are rigidly secured to theclamping member 53 and the motor 47, respectively. The second clampingmember 54 has a pinion in mesh with the worm gear 55. When the motor 47is powered, the worm gear 55 rotates, and will thereby pull the endportion 39 of the core 37 in one or the opposite longitudinal direction,so that the diameter of the substantially circular core 37 is eitherincreased or decreased. The motor 47, worm gear 55, gear transmission 56and second clamping member 54 constitute a servo system of the type thattransfers a weak force acting on a moving element having a long strokeinto a strong force acting on another moving element having a shortstroke.

FIG. 20 shows a constriction device including a plurality of arcuatelamellae 59 arranged like the conventional adjustable aperture mechanismof a camera. A motor 60 operates the lamellae 59 to change the size of arestriction opening defined by the lamellae 59.

FIGS. 21-23 show a constriction device including two semi-circularelements 61 and 62, which are hinged together such that thesemi-circular elements 61, 62 are swingable relative to each otherbetween a fully open state in which they substantially form a circle, asillustrated in FIG. 22, and an angular state, in which the size of therestriction opening defined by the semi-circular elements 61, 62 isreduced, as illustrated in FIG. 23. A motor 63 operates thesemi-circular elements 61, 62 to swing them relative to each other.

FIGS. 24-26 show a constriction device including an elastic belt 64forming a circle and having a substantially oval cross-section. A motor67 operates the belt 64 to turn around the longitudinal extensionthereof between a fully open state, in which the inner broader side ofthe belt 64 forms a substantially cylindrical surface, as illustrated inFIG. 25, and a reduced open state, in which the inner broader side ofthe belt 64 forms a substantially conical surface, as illustrated inFIG. 26.

FIG. 27 shows a constriction device 68 having two rigid articulatedclamping elements 69 positioned on opposite sides of a portion of atubular tissue wall 70 of a patient's organ. An operation device 71turns the clamping elements 69 toward each other to clamp the wallportion 70 between the clamping elements 69 to thereby contract the wallportion, and turns the clamping elements 69 away from each other torelease the wall portion from the clamping elements 69.

FIGS. 28 and 29 show an embodiment of the apparatus of the inventioncomprising a constriction device 300 having three bending members 301,302 and 303 displaced relative to one another in a row along a portionof a tubular tissue wall 304 of a patient's organ and positionedalternately on opposite sides of the tubular wall 304. (Alternatively,each member 301, 302 and 303 may take the shape of an hour-glass.) Anoperation device (not shown) moves the two outer members 301, 303laterally against the tubular wall 304 in one direction and theintermediate member 302 against the tubular wall 304 in the oppositedirection to bend the tubular wall 304, to thereby constrict the tubularwall portion 304, as illustrated in FIG. 29. To release the wall portion304 the operation device moves the members 301-303 away from the tubularwall portion 304 to the position shown in FIG. 28.

FIGS. 30A and 30B show a hydraulically operable elongated constrictiondevice in the form of a band 72 having an expandable/contractible cavity73, which is in fluid communication with an adjustable reservoir 74containing hydraulic fluid. FIG. 30A illustrates when the band is in anon-constriction state, whereas FIG. 30B illustrates when the band is ina constriction state, in which the cavity 73 is expanded by hydraulicfluid supplied by the reservoir 74.

FIGS. 31A, 31B, 31C and 31D are block diagrams of four differentlyoperated hydraulic constriction devices. FIG. 31A shows the band 72 ofFIG. 30A, the cavity 73 of which is in fluid communication with areservoir 75. FIG. 31B shows the embodiment of FIG. 30A, in which thecavity 73 of the band 72 is in fluid communication with the reservoir 74via an operation device in the form of a two-way pump 76. FIG. 31C showsan operation device in the form of a reverse servo system with a firstclosed system controlling a second system. The reverse servo systemcomprises an adjustable fluid supply reservoir 77 and an adjustableservo reservoir 78. The servo reservoir 78 controls a larger adjustablereservoir 79 which in connection with the band 72 applied around aportion of tubular tissue wall of a patient's organ varies the volume ofthe cavity 73 of the band 72, which in turn varies the constriction ofthe wall portion. FIG. 31D shows an embodiment identical to theembodiment of FIG. 31C, except that the larger reservoir 79 is omitted.Instead, the servo reservoir 78 is in fluid communication with thecavity of the band 72.

In all of the above embodiments according to FIGS. 12A through 30B,stimulation devices may be provided to form constriction/stimulationunits, in which the stimulation devices include a multiplicity ofelectrical elements 7 (indicated in FIGS. 12A-15, 18, 20-23, 26-31B)positioned on the constriction devices.

FIG. 32 is a cross-sectional view of a fluid supply device including abellows reservoir 80 defining a chamber 81, the size of which isvariable by an operation device comprising a remote controlled electricmotor 82. The reservoir 80 and the motor 82 are placed in a housing 83.Moving a large wall 84 varies the chamber 81. The wall 84 is secured toa nut 85, which is threaded on a rotatable spindle 86. The spindle 86 isrotated by the motor 82. A battery 89 placed in the housing 83 powersthe motor 82. A signal receiver 90 for controlling the motor 82 is alsoplaced in the housing 83. Alternatively, the battery 89 and the signalreceiver 90 may be mounted in a separate place. The motor 82 may also bepowered with energy transferred from transmitted signals.

Where applicable, the fluid supply device of FIG. 32 may be used forsupplying hydraulic fluid for the operation of the constriction devicesdescribed in this specification. For example, the fluid supply device ofFIG. 32 may be substituted for the reservoir 74 in the embodimentaccording to FIG. 30A.

FIGS. 33A and 33B show a reverse servo including a rectangular housing91 and an intermediate wall 92, which is movable in the housing 91. Arelatively large, substantially cylindrical bellows reservoir 93 isarranged in the housing 91 and is joined to the movable intermediatewall 92. Another cylindrical bellows reservoir 94, which issubstantially smaller than reservoir 93, is arranged in the housing 91at the other side of the intermediate wall 92 and is also joined to thewall 92. The small bellows reservoir 94 has a fluid supply pipe 95 andthe large bellows reservoir 93 has a fluid supply pipe 96.

Referring to FIG. 33A, when a small amount of hydraulic fluid isconducted through the supply pipe 95 into the small bellows reservoir94, the small bellows reservoir 94 expands and pushes the movableintermediate wall 92 towards the large bellows reservoir 93. As aresult, the large bellows reservoir 93 is contracted by the intermediatewall 92, whereby a large amount of hydraulic fluid is forced out of thelarge bellows reservoir 93 through the supply pipe 96, as shown in FIG.338.

For example, the reverse servo of FIGS. 33A and 33B may be used in theembodiment of FIG. 31C, wherein the small bellows reservoir 94corresponds to the small servo reservoir 78 and the large bellowsreservoir 93 corresponds to the large reservoir 79. Also, the reverseservo of FIGS. 33A and 33B may be used in the embodiment of FIGS. 30Aand 30B, wherein the small bellows reservoir 94 is connected to theadjustable reservoir 74, and the large bellows reservoir 93 is connectedto the cavity 73 of the band 72.

FIG. 34 schematically shows a hydraulically operable constriction device97 of the apparatus of the invention, which is similar to the embodimentshown in FIG. 30A, except that the hydraulic system is designeddifferently. Thus, the constriction device 97 includes a relativelysmall inflatable cavity 98, which is in fluid communication with areservoir 99 containing hydraulic fluid, and a relatively large cavity100, which is displaceable by small cavity 98. Small cavity 98 isadapted to displace large cavity 100 to constrict the patient's tubularwall portion when small cavity 98 is inflated and to displace largecavity 100 to release the wall portion when small cavity 98 is deflated.Thus, a relatively small addition of hydraulic fluid from reservoir 99to small cavity 98 causes a relatively large increase in theconstriction of the wall portion.

Large cavity 100 is defined by a contraction element in the form of abig balloon 101, which may be connected to an injection port (not shown)for calibration of the volume of large cavity 100. Adding fluid to orwithdrawing fluid from the injection port with the aid of a syringecalibrates the volume of balloon 101. Small cavity 98 is defined by asmall bellows 102 attached to an annular frame 103 of constrictiondevice 97 and at the opposite end is attached to balloon 101.

FIGS. 35A and 35B schematically illustrate the operation of constrictiondevice 97, when annular frame 103 is applied around the tubular wallportion of the patient's organ. Referring to FIG. 35A, when small cavity98 is deflated bellows 102 pulls balloon 101 inwardly into annular frame103, so that constriction device 97 constricts the wall portion.Referring to FIG. 35B, when small cavity 98 is inflated bellows 102pulls balloon 101 out of annular frame 103, so that constriction device97 releases the wall portion.

As mentioned above, the constriction device and stimulation device canco-operate to actively move the fluid and/or other bodily matter in thelumen of a patient's organ. This can be achieved using theconstriction/stimulation unit shown in FIG. 2. Thus, in accordance witha first cooperation option, the clamping elements 5, 6 of theconstriction device constricts the wall portion 8 without completelyclosing the lumen, whereby the flow in the lumen is restricted, and thecontrol device 4 controls the electrical elements 7 to progressivelystimulate the constricted wall portion in the downstream or upstreamdirection of the lumen to cause progressive contraction of the wallportion 8 to move the fluid and/or other bodily matter in the lumen.

In accordance with a second cooperation option, the constriction deviceconstricts the wall portion so that the flow in the lumen is restricted,and the control device 4 controls a few electrical elements 7 at one endof the elongate clamping elements 5, 6 to stimulate the constricted wallportion 8 to close the lumen either at an upstream end or a downstreamend of the wall portion 8. With the lumen closed in this manner, thecontrol device 4 controls the constriction device to increase theconstriction of the wall portion, whereby the fluid and/or other bodilymatter in the lumen is moved downstream or upstream of the wall portion8.

In another embodiment of the invention for performing the secondcooperation option, the constriction device constricts the wall portionso that the flow in the lumen is restricted, and the control device 4controls the stimulation device to stimulate the constricted wallportion while the constriction device varies the constriction of thedifferent areas of the wall portion, such that the wall portion isprogressively constricted in the downstream or upstream direction of thelumen. FIGS. 36A-36E show different operation stages of such analternative embodiment, which comprises a constriction device 104including two elongate constriction elements 105, 106 having convexsurfaces 107, 108 that abut a length of the wall portion 8 on mutualsides thereof, and a multiplicity of electrical elements 7 (such aselectrodes) that are positioned on the convex surfaces 107, 108. Thecontrol device 4 controls the electrical elements 7 during operation ofthe constriction device 104 and controls the elongate constrictionelements 105, 106 to move relative to the tubular wall portion 8 so thatthe constriction elements 105, 106 progressively constrict the wallportion 8, as appears from FIGS. 36A to 36D.

Thus, in an initial position of the constriction elements 105, 106 shownin FIG. 36A, the wall portion is not constricted by the constrictionelements 105, 106 and the electrical elements 7 are not energized.Starting from this initial position, the control device 4 controls theconstriction elements 105, 106 to swing the left ends of theconstriction elements 105, 106 toward the wall portion (indicated byarrows) to constrict the tubular wall portion 8, see FIG. 36B, whileenergizing the electrical elements 7, so that the electrical elements 7that contact the wall portion 8 contract the latter. FIG. 36 C shows howthe lumen of the tubular wall portion 8 is completely closed by thethickened wall portion 8. Then, as shown in FIG. 36C, the control device4 controls the constriction elements 105, 106 to move so that theirright ends are moving towards each other (indicated by arrows), whilethe convex surfaces 107, 108 of the constriction elements 105, 106 arerolling on each other with the contracted wall portion 8 between them,see FIG. 36D. As a result, the bodily matter in the lumen of the organis forced to the right (indicated by a white arrow). When theconstriction elements 105, 106 have rolled on each other to the positionshown in FIG. 36E, the control device 4 controls the right ends of theconstriction elements 105, 106 to move away from each other (indicatedby arrows in FIG. 36E) to the initial position shown in FIG. 36A. Theoperation stages described according to FIGS. 36A to 36E can becyclically repeated a number of times until the desired amount of bodilymatter has been moved in the lumen of the organ in a peristaltic manner.

Alternatively, only one of the constriction elements 105, 106 can beprovided with a convex surface, whereas the other constriction elementhas a plane surface that abuts the wall portion. It is also possible touse a single constriction element with a convex surface that presses thetubular portion 8 of the organ against a bone of the patient.

In the embodiment according to FIGS. 36A to 36E, the control device 4may control the electrical elements 7 to progressively stimulate theconstricted wall portion 8 to cause progressive contraction thereof inharmony with the movement of the elongate constriction elements 105,106, as the convex surfaces 107, 108 of the constriction elements 105,106 are rolling on each other. FIG. 37 schematically shows a generalembodiment of the apparatus of the invention, in which energy istransferred to energy consuming components of the apparatus implanted inthe patient. The apparatus of FIG. 37 comprises an implantedconstriction/stimulation unit 110, which is operable to gently constricta portion of a tubular tissue wall of a patient's organ and to stimulatedifferent areas of the constricted portion to cause contraction of thewall portion. The constriction device of the constriction/stimulationunit 110 is capable of performing a reversible function, i.e., toconstrict and release the wall portion, so that theconstriction/stimulation unit 110 works as an artificial sphincter.

A source of energy 111 is adapted to supply energy consuming componentsof the constriction/stimulation unit 110 with energy via a power supplyline 112. A wireless remote control or a subcutaneously implanted switchoperable by the patient to switch on or off the supply of energy fromthe source of energy may be provided. The source of energy may be animplantable permanent or rechargeable battery, or be included in anexternal energy-transmission device, which may be operable directly bythe patient or be controlled by a remote control operable by the patientto transmit wireless energy to the energy consuming components of theconstriction/stimulation unit. Alternatively, the source of energy maycomprise a combination of an implantable rechargeable battery, anexternal energy-transmission device and an implantableenergy-transforming device for transforming wireless energy transmittedby the external energy-transmission device into electric energy for thecharge of the implantable rechargeable battery.

FIG. 38 shows a special embodiment of the general embodiment of FIG. 37having some parts implanted in a patient and other parts located outsidethe patient's body. Thus, in FIG. 38 all parts placed to the right ofthe patient's skin 109 are implanted and all parts placed to the left ofthe skin 109 are located outside the patient's body. An implantedenergy-transforming device 111A of the apparatus is adapted to supplyenergy consuming components of the constriction/stimulation unit 110with energy via the power supply line 112. An externalenergy-transmission device 113 of the apparatus includes a wirelessremote control transmitting a wireless signal, which is received by asignal receiver incorporated in the implanted energy-transforming device111A. The implanted energy-transforming device 111A transforms energyfrom the signal into electric energy, which is supplied via the powersupply line 112 to the constriction/stimulation unit 110.

The apparatus of FIG. 38 may also include an implanted rechargeablebattery for energizing energy consuming implanted components of theapparatus. In this case, the implanted energy-transforming device 111Aalso charges the battery with electric energy, as theenergy-transforming device transforms energy from the signal into theelectric energy.

A reversing device in the form of an electric switch 114, such as amicroprocessor, is implanted in the patient for reversing theconstriction device of the constriction/stimulation unit 110. Thewireless remote control of the external energy-transmission device 113transmits a wireless signal that carries energy and the implantedenergy-transforming device 111A transforms the wireless energy into acurrent for operating the switch 114. When the polarity of the currentis shifted by the energy-transforming-device 111A the switch 114reverses the function performed by the constriction device of theconstriction/stimulation unit 110.

FIG. 39 shows an embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110and an implanted operation device in the form of a motor 115 foroperating the constriction device of the constriction/stimulation unit110. The motor 115 is powered with energy from the energy-transformingdevice 111A, as the remote control of the external energy-transmissiondevice 113 transmits a wireless signal to the receiver of theenergy-transforming device 111A.

FIG. 40 shows an embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110and an implanted assembly 116 including a motor/pump unit 117 and afluid reservoir 118. In this case the constriction device of theconstriction/stimulation unit 110 is hydraulically operated, i.e.,hydraulic fluid is pumped by the motor/pump unit 117 from the reservoir118 to the constriction/stimulation unit 110 to constrict the wallportion, and hydraulic fluid is pumped by the motor/pump unit 117 backfrom the constriction/stimulation unit 110 to the reservoir 118 torelease the wall portion. The implanted energy-transforming device 111Atransforms wireless energy into a current, for powering the motor/pumpunit 117.

FIG. 41 shows an embodiment of the invention comprising the externalenergy-transmission device 113 that controls the control unit 122 toreverse the motor 115 when needed, the constriction/stimulation unit110, the constriction device of which is hydraulically operated, and theimplanted energy-transforming device 111A, and further comprising animplanted hydraulic fluid reservoir 119, an implanted motor/pump unit120, an implanted reversing device in the form of a hydraulic valveshifting device 121 and a separate external wireless remote control111B. The motor of the motor/pump unit 120 is an electric motor. Inresponse to a control signal from the wireless remote control of theexternal energy-transmission device 113, the implantedenergy-transforming device 111A powers the motor/pump unit 120 withenergy from the energy carried by the control signal, whereby themotor/pump unit 120 distributes hydraulic fluid between the reservoir119 and the constriction device of the constriction/stimulation unit110. The remote control 111B controls the shifting device 121 to shiftthe hydraulic fluid flow direction between one direction in which thefluid is pumped by the motor/pump unit 120 from the reservoir 119 to theconstriction device of the constriction/stimulation unit 110 toconstrict the wall portion, and another opposite direction in which thefluid is pumped by the motor/pump unit 120 back from the constrictiondevice of the constriction/stimulation unit 110 to the reservoir 119 torelease the wall portion.

FIG. 42 shows an embodiment of the invention including theenergy-transforming device 111A and the constriction/stimulation unit110. A control unit 122, an accumulator 123 and a capacitor 124 are alsoimplanted in the patient. A separate external wireless remote control111B controls the control unit 122. The control unit 122 controls theenergy-transforming device 111A to store electric energy in theaccumulator 123, which supplies energy to the constriction/stimulationunit 110. In response to a control signal from the wireless remotecontrol 111B, the control unit 122 either releases electric energy fromthe accumulator 123 and transfers the released energy via power lines,or directly transfers electric energy from the energy-transformingdevice 111A via the capacitor 124, which stabilises the electriccurrent, for the operation of the constriction/stimulation unit 110.

In accordance with one alternative, the capacitor 124 in the embodimentof FIG. 42 may be omitted. In accordance with another alternative, theaccumulator 123 in this embodiment may be omitted.

FIG. 43 shows an embodiment of the invention including theenergy-transforming device 111A, the constriction/stimulation unit 110.A battery 125 for supplying energy for the operation of theconstriction/stimulation unit 110 and an electric switch 126 forswitching the operation of the constriction/stimulation unit 110 arealso implanted in the patient. The switch 126 is operated by the energysupplied by the energy-transforming device 111A to switch from an offmode, in which the battery 125 is not in use, to an on mode, in whichthe battery 125 supplies energy for the operation of theconstriction/stimulation unit 110.

FIG. 44 shows an embodiment of the invention identical to that of FIG.43, except that a control unit 122 also is implanted in the patient. Aseparate external wireless remote control 111B controls the control unit122. In this case, the switch 126 is operated by the energy supplied bythe energy-transforming device 111A to switch from an off mode, in whichthe wireless remote control 111B is prevented from controlling thecontrol unit 122 and the battery 125 is not in use, to a standby mode,in which the remote control 111B is permitted to control the controlunit 122 to release electric energy from the battery 125 for theoperation of the constriction/stimulation unit 110.

FIG. 45 shows an embodiment of the invention identical to that of FIG.44, except that the accumulator 123 is substituted for the battery 125and the implanted components are interconnected differently. In thiscase, the accumulator 123 stores energy from the energy-transformingdevice 111A. In response to a control signal from the wireless remotecontrol 111B, the implanted control unit 122 controls the switch 126 toswitch from an off mode, in which the accumulator 123 is not in use, toan on mode, in which the accumulator 123 supplies energy for theoperation of the constriction/stimulation unit 110.

FIG. 46 shows an embodiment of the invention identical to that of FIG.45, except that the battery 125 also is implanted in the patient, andthe implanted components are interconnected differently. In response toa control signal from the wireless remote control 111B, the implantedcontrol unit 122 controls the accumulator 123, which may be a capacitor,to deliver energy for operating the switch 126 to switch from an offmode, in which the battery 125 is not in use, to an on mode, in whichthe battery 125 supplies electric energy for the operation of theconstriction/stimulation unit 110.

Alternatively, the switch 126 may be operated by energy supplied by theaccumulator 123 to switch from an off mode, in which the wireless remotecontrol 111B is prevented from controlling the battery 125 to supplyelectric energy and the battery 125 is not in use, to a standby mode, inwhich the wireless remote control 111B is permitted to control thebattery 125 to supply electric energy for the operation of theconstriction/stimulation unit 110.

FIG. 47 shows an embodiment of the invention identical to that of FIG.43, except that a motor 115, a mechanical reversing device in the formof a gearbox 127 and a control unit 122 for controlling the gearbox 127also are implanted in the patient. A separate external wireless remotecontrol 111B controls the implanted control unit 122 to control thegearbox 127 to reverse the function performed by the constriction device(mechanically operated) of the constriction/stimulation unit 110.

FIG. 48 shows an embodiment of the invention identical to that of FIG.46, except that the implanted components are interconnected differently.Thus, in this case, the battery 125 powers the control unit 122 when theaccumulator 123, suitably a capacitor, activates the switch 126 toswitch to an on mode. When the switch 126 is in its on mode the controlunit 122 is permitted to control the battery 125 to supply, or notsupply, energy for the operation of the constriction/stimulation unit110.

FIG. 49 shows an embodiment of the invention identical to that of FIG.39, except that a gearbox 127 that connects the motor 115 to theconstriction/stimulation unit 110, and a control unit 122 that controlsthe energy-transforming device 111A to power the motor 115 also areimplanted in the patient. There is a separate external wireless remotecontrol 111B that controls the control unit 122 to reverse the motor 115when needed.

Optionally, the accumulator 123 shown in FIG. 42 may be provided in theembodiment of FIG. 49, wherein the implanted control unit 122 controlsthe energy-transforming device 111A to store the transformed energy inthe accumulator 123. In response to a control signal from the wirelessremote control 111B, the control unit 122 controls the accumulator 123to supply energy for the operation of the constriction/stimulation unit110.

Those skilled in the art will realise that the above various embodimentsaccording to FIGS. 38-49 could be combined in many different ways. Forexample, the energy operated switch 114 could be incorporated in any ofthe embodiments of FIGS. 39, 42-49, the hydraulic shifting device 121could be incorporated in the embodiment of FIG. 40, and the gearbox 127could be incorporated in the embodiment of FIG. 39. The switch 114 maybe of a type that includes electronic components, for example amicroprocessor, or a FGPA (Field Programmable Gate Array) designed forswitching. Alternatively, however, the energy operated switch 114 may bereplaced by a subcutaneously implanted push button that is manuallyswitched by the patient between “on” and“off”.

Alternatively, a permanent or rechargeable battery may be substitutedfor the energy-transforming devices 111A of the embodiments shown inFIGS. 38-49.

FIG. 50 shows the energy-transforming device in the form of anelectrical junction element 128 for use in any of the above embodimentsaccording to FIGS. 37-49. The element 128 is a flat p-n junction elementcomprising a p-type semiconductor layer 129 and an n-type semiconductorlayer 130 sandwiched together. A light bulb 131 is electricallyconnected to opposite sides of the element 128 to illustrate how thegenerated current is obtained. The output of current from such a p-njunction element 128 is correlated to the temperature. See the formulabelow.I=I0(exp(qV/kT)−1)

Where

I is the external current flow,

I0 is the reverse saturation current,

q is the fundamental electronic charge of 1.602×10-19 coulombs,

V is the applied voltage,

k is the Boltzmann constant, and

T is the absolute temperature.

Under large negative applied voltage (reverse bias), the exponentialterm becomes negligible compared to 1.0, and I is approximately −I0. I0is strongly dependent on the temperature of the junction and hence onthe intrinsic-carrier concentration. I0 is larger for materials withsmaller bandgaps than for those with larger bandgaps. The rectifieraction of the diode, that is, its restriction of current flow to onlyone direction, is in this particular embodiment the key to the operationof the p-n junction element 128.

The alternative way to design a p-n junction element is to deposit athin layer of semiconductor onto a supporting material which does notabsorb the kind of energy utilised in the respective embodiments. Foruse with wirelessly transmitted energy in terms of light waves, glasscould be a suitable material. Various materials may be used in thesemiconductor layers, such as, but not limited to, cadmium telluride,copper-indium-diselenide and silicon. It is also possible to use amultilayer structure with several layers of p and n-type materials toimprove efficiency.

The electric energy generated by the p-n junction element 128 could beof the same type as generated by solar cells, in which the negative andpositive fields create a direct current. Alternatively, the negative andpositive semiconductor layers may change polarity following thetransmitted waves, thereby generating the alternating current.

The p-n junction element 128 is designed to make it suited forimplantation. Thus, all the external surfaces of the element 128 incontact with the human body are made of a biocompatible material. Thep-n junction semiconductors are designed to operate optimally at a bodytemperature of 37° C. because the current output, which should be morethan 1 μA, is significantly dependent upon such temperature, as shownabove. Since both the skin and subcutis absorb energy, the relationbetween the sensitivity or working area of the element 128 and theintensity or strength of the wireless energy-transmission is considered.The p-n junction element 128 preferably is designed flat and small.Alternatively, if the element 128 is made in larger sizes it should beflexible, in order to adapt to the patient's body movements. The volumeof the element 128 should be kept less than 2000 cm³.

FIG. 51 shows basic parts of a remote control of the apparatus of theinvention for controlling the constriction/stimulation unit 110. In thiscase, the stimulation device of the constriction/stimulation unitstimulates the wall portion with electric pulses. The remote control isbased on wireless transmission of electromagnetic wave signals, often ofhigh frequencies in the order of 100 kHz-1 gHz, through the skin 132 ofthe patient. In FIG. 51, all parts placed to the left of the skin 132are located outside the patient's body and all parts placed to the rightof the skin 132 are implanted.

An external signal-transmission device 133 is to be positioned close toa signal-receiving device 134 implanted close to the skin 132. As analternative, the signal-receiving device 134 may be placed for exampleinside the abdomen of the patient. The signal-receiving device 134comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter,wound with a very thin wire and tuned with a capacitor to a specifichigh frequency. A small coil is chosen if it is to be implanted underthe skin of the patient and a large coil is chosen if it is to beimplanted in the abdomen of the patient. The signal transmission device133 comprises a coil having about the same size as the coil of thesignal-receiving device 134 but wound with a thick wire that can handlethe larger currents that is necessary. The coil of the signaltransmission device 133 is tuned to the same specific high frequency asthe coil of the signal-receiving device 134.

The signal-transmission device 133 is adapted to send digitalinformation via the power amplifier and signal-receiving device 134 toan implanted control unit 135. To avoid that accidental random highfrequency fields trigger control commands, digital signal codes areused. A conventional keypad placed on the signal transmission device 133is used to order the signal transmission device 133 to send digitalsignals for the control of the constriction/stimulation unit. The signaltransmission device 133 starts a command by generating a high frequencysignal. After a short time, when the signal has energized the implantedparts of the control system, commands are sent to operate theconstriction device of the constriction/stimulation unit 110 inpredefined steps. The commands are sent as digital packets in the formillustrated below.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands are sent continuously during a rather long time period(e.g., about 30 seconds or more). When a new constriction or releasestep is desired, the Count byte is increased by one to allow theimplanted control unit 135 to decode and understand that another step isdemanded by the signal transmission device 133. If any part of thedigital packet is erroneous, its content is simply ignored.

Through a line 136, an implanted energizer unit 137 draws energy fromthe high frequency electromagnetic wave signals received by thesignal-receiving device 134. The energizer unit 137 stores the energy ina source of energy, such as a large capacitor, powers the control unit135 and powers the constriction/stimulation unit 110 via a line 138.

The control unit 135 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the signaltransmission device 133. The microprocessor receives the digital packet,decodes it and sends a control signal via a signal line 139 to controlthe constriction device of the constriction/stimulation unit 110 toeither constrict or release the wall portion of the patient's organdepending on the received command code.

FIG. 52 shows a circuitry of an embodiment of the invention, in whichwireless energy is transformed into a current. External components ofthe circuitry include a microprocessor 140, a signal generator 141 and apower amplifier 142 connected thereto. The microprocessor 140 is adaptedto switch the signal generator 141 on/off and to modulate signalsgenerated by the signal generator 141 with digital commands. The poweramplifier 142 amplifies the signals and sends them to an externalsignal-transmitting antenna coil 143. The antenna coil 143 is connectedin parallel with a capacitor 144 to form a resonant circuit tuned to thefrequency generated by the signal generator 141.

Implanted components of the circuitry include a signal receiving antennacoil 145 and a capacitor 146 forming together a resonant circuit that istuned to the same frequency as the transmitting antenna coil 143. Thesignal receiving antenna coil 145 induces a current from the receivedhigh frequency electromagnetic waves and a rectifying diode 147rectifies the induced current which charges a storage capacitor 148. Thestorage capacitor 148 powers a motor 149 for driving the constrictiondevice of the constriction/stimulation unit 110. A coil 150 connectedbetween the antenna coil 145 and the diode 147 prevents the capacitor148 and the diode 147 from loading the circuit of the signal-receivingantenna 145 at higher frequencies. Thus, the coil 150 makes it possibleto charge the capacitor 148 and to transmit digital information usingamplitude modulation.

A capacitor 151 and a resistor 152 connected in parallel and a diode 153form a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 154 connected in series with aresistor 155 connected in series with a capacitor 156 connected inseries with the resistor 154 via ground, and a capacitor 157, oneterminal of which is connected between the resistors 154,155 and theother terminal of which is connected between the diode 153 and thecircuit formed by the capacitor 151 and resistor 152. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 158 thatdecodes the digital information and controls the motor 149 via anH-bridge 159 comprising transistors 160, 161, 162 and 163. The motor 149can be driven in two opposite directions by the H-bridge 159.

The microprocessor 158 also monitors the amount of stored energy in thestorage capacitor 148. Before sending signals to activate the motor 149,the microprocessor 158 checks whether the energy stored in the storagecapacitor 148 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 158 waits for the receivedsignals to charge the storage capacitor 148 before activating the motor149.

Alternatively, the energy stored in the storage capacitor 148 may onlybe used for powering a switch, and the energy for powering the motor 149may be obtained from another implanted energy source of relatively highcapacity, for example a battery. In this case the switch is adapted toconnect the battery to the motor 149 in an on mode when the switch ispowered by the storage capacitor 148 and to keep the batterydisconnected from the motor 149 in a standby mode when the switch is notpowered.

FIGS. 53A-53C show an embodiment of the invention, which is similar tothe embodiment of FIG. 2, except that the constriction/stimulation unit,here denoted by reference numeral 200, is provided with additionalclamping elements. The embodiment of FIGS. 53A-53C is suited foractively moving the fluid and/or other bodily matter in the lumen of apatient's organ. Thus, the constriction/stimulation unit 200 alsoincludes a first pair of short clamping elements 201 and 202, and asecond pair of short clamping elements 203 and 204, wherein the firstand second pairs of clamping elements are positioned at mutual sides ofthe elongate clamping elements 5, 6. The two short clamping elements201, 202 of the first pair are radially movable towards and away fromeach other between retracted positions (FIG. 53A) and clamping positions(FIGS. 53B and 53C), and the two short clamping elements 203, 204 of thesecond pair are radially movable towards and away from each otherbetween retracted positions (FIG. 53C) and clamping positions (FIGS. 53Aand 53B). The stimulation device 3 also includes electrical elements 7positioned on the short clamping elements 201-204, so that theelectrical elements 7 on one of the short clamping elements 201 and 203,respectively, of each pair of short elements face the electricalelements 7 on the other short clamping element 202 and 204,respectively, of each pair of short elements.

The constriction/stimulation unit 200 is applied on a wall portion 8 ofa tubular tissue wall of a patient's organ, so that the short clampingelements 201, 202 are positioned at an upstream end of the wall portion8, whereas the short clamping elements 203, 204 202 are positioned at adownstream end of the wall portion 8. In FIGS. 53A to 53C the upstreamend of the wall portion 8 is to the left and the downstream end of thewall portion 8 is to the right.

The control device 4 controls the pair of short clamping elements 201,202, the pair of elongate clamping elements 5, 6 and the pair of shortelements 203, 204 to constrict and release the wall portion 8independently of one another. The control device also controls theelectrical elements 7 on a clamping element that is constricting thewall portion to stimulate the constricted wall portion 8 with electricpulses to cause contraction of the wall portion 8, so that the lumen ofthe wall portion 8 is closed.

FIGS. 53A-53C illustrate how the control device 4 controls the operationof the constriction/stimulation unit 200 to cyclically move fluid and/orother bodily matter downstream in the lumen of the wall portion 8. Thus,in FIG. 53A the short clamping elements 201, 202 and the elongateclamping elements 5, 6 are in their retracted positions, whereas theshort clamping elements 203, 204 are in their clamping positions whilethe electrical elements 7 on elements 203, 204 electrically stimulatethe wall portion 8. The electrical stimulation causes the wall portion 8at the elements 203, 204 to thicken, whereby the lumen is closed. FIG.53B illustrates how also the short clamping elements 201, 202 have beenmoved radially inwardly to their clamping positions, while theelectrical elements 7 on elements 201, 202 electrically stimulate thewall portion 8, whereby a volume of bodily matter is trapped in thelumen between the upstream and downstream ends of the wall portion 8.FIG. 53C illustrates how initially the short clamping elements 203, 204have been moved radially outwardly to their retracted positions, andthen the elongate clamping elements 5, 6 have been moved radiallyinwardly to their clamping positions while the electrical elements 7 onelements 5, 6 electrically stimulate the wall portion 8. As a result,the bodily matter in the lumen between the upstream and downstream endsof the wall portion 8 has been moved downstream in the lumen Then, thecontrol device 4 controls the constriction/stimulation unit 200 toassume the state shown in FIG. 53A, whereby bodily matter may flow intoand fill the lumen between the upstream and downstream ends of the wallportion 8, so that the cycle of the operation is completed.

Alternatively, the operation cycle of the constriction/stimulation unit200 described above may be reversed, in order to move bodily matterupstream in the lumen. In this case, the control device 4 controls theshort clamping elements 203, 204 to constrict the wall portion 8 at thedownstream end thereof to restrict the flow in the lumen and controlsthe electric elements 7 to stimulate the constricted wall portion 8 withelectric pulses at the downstream end to close the lumen. With the lumenclosed at the downstream end of the constricted wall portion 8 and theshort clamping elements 201, 202 in their retracted positions, as shownin FIG. 53A, the control device 4 controls the elongate clampingelements 5, 6 to constrict the wall portion 8 between the upstream anddownstream ends thereof. As a result, the fluid and/or other bodilymatter contained in the wall portion 8 between the upstream anddownstream ends thereof is moved upstream in the lumen.

Although FIGS. 53A-53C disclose pairs of clamping elements, it should benoted that it is conceivable to design the constriction/stimulation unit200 with only a single short clamping element 201, a single elongateclamping element 5 and a single short clamping element 203. In this casethe bottom of the tubular wall portion 8 is supported by stationaryelements of the constriction/stimulation unit 200 opposite to theclamping elements 201, 5, and 203.

FIGS. 54A and 54B schematically show another embodiment of theinvention, in which a constriction/stimulation unit 205 is designed foractively moving the fluid and/or other bodily matter in the lumen of apatient's tubular organ. The constriction device 206 of theconstriction/stimulation unit 205 includes a rotor 207, which carriesthree cylindrical constriction elements 208A, 208B and 208C positionedequidistantly from the axis 209 of the rotor 207. The constrictionelements 208A-208C may be designed as rollers. Each cylindrical element208A-208C is provided with electrical elements 7. A stationary elongatesupport element 210 is positioned spaced from but close to the rotor 207and has a part cylindrical surface 211 concentric with the axis 209 ofthe rotor 207. The constriction/stimulation unit 205 is applied on apatient's tubular organ 212, so that the organ 212 extends between thesupport element 210 and the rotor 207.

The control device 4 controls the rotor 207 of the constriction deviceto rotate, such that the constriction elements 208A-208C successivelyconstrict wall portions of a series of wall portions of the tubularorgan 212 against the elongate support element 210. The electricalelements 7 of the constriction elements 208A-208C stimulate theconstricted wall portions with electric pulses so that the wall portionsthicken and close the lumen of the organ 212. FIG. 54A illustrates howthe constriction element 208A has started to constrict the wall of theorgan 212 and how the lumen of the organ 212 is closed with the aid ofthe electrical elements 7 on the constriction element 208A, whereas theconstriction element 208B is about to release the organ 212. FIG. 54Billustrates how the constriction element 208A has advanced about halfwayalong the elongate support element 210 and moved the bodily matter inthe lumen in a direction indicated by an arrow. The constriction element208B has released the organ 212, whereas the constriction element 208Cis about to engage the organ 212. Thus, the control device 4 controlsthe rotor 207 to cyclically move the constriction elements 208A-208C,one after the other, along the elongate support element 210, whileconstricting the wall portions of the organ 212, so that the bodilymatter in the organ 212 is moved in a peristaltic manner.

FIGS. 55A, 55B and 55C show another mechanically operable constrictiondevice 213 for use in the apparatus of the invention. Referring to FIG.55A, the constriction device 213 includes a first ring-shaped holder 214applied on a tubular organ 8 of a patient and a second ring-shapedholder 215 also applied on the organ 8 spaced apart from holder 214.There are elastic strings 216 (here twelve strings) that extend inparallel along the tubular organ 8 and interconnect the two holders 213,214 without contacting the organ 8. FIG. 55A illustrate an inactivatedstate of the constriction device 213 in which the organ 8 is notconstricted.

Referring to FIGS. 55B and 55C, when organ 8 is to be constricted thering-shaped holders 213 and 214 are rotated by an operation means (notshown) in opposite directions, whereby the elastic strings 216 constrictthe organ 8 in a manner that appears from FIGS. 55B and 55C. For thesake of clarity, only five strings 216 are shown in FIG. 55B.

In accordance with the present invention, electrodes for electricallystimulating the organ 8 to cause contraction of the wall of the organ 8are attached to the strings 216 (not shown in FIGS. 55A-55C).

FIG. 56 schematically illustrates an arrangement of the apparatus thatis capable of sending information from inside the patient's body to theoutside thereof to give information related to at least one functionalparameter of the apparatus, and/or related to a physical parameter ofthe patient, in order to supply an accurate amount of energy to animplanted internal energy receiver 302 connected to energy consumingcomponents of an implanted constriction/stimulation unit 301 of theapparatus of the invention. Such an energy receiver 302 may include asource of energy and/or an energy-transforming device. Brieflydescribed, wireless energy is transmitted from an external source ofenergy 304 a located outside the patient and is received by the internalenergy receiver 302 located inside the patient. The internal energyreceiver is adapted to directly or indirectly supply received energy tothe energy consuming components of the constriction/stimulation unit 301via a switch 326. An energy balance is determined between the energyreceived by the internal energy receiver 302 and the energy used for theconstriction/stimulation unit 301, and the transmission of wirelessenergy is then controlled based on the determined energy balance. Theenergy balance thus provides an accurate indication of the correctamount of energy needed, which is sufficient to operate theconstriction/stimulation unit 301 properly, but without causing unduetemperature rise.

In FIG. 56 the patient's skin is indicated by a vertical line 305. Here,the energy receiver comprises an energy-transforming device 302 locatedinside the patient, preferably just beneath the patient's skin 305.Generally speaking, the implanted energy-transforming device 302 may beplaced in the abdomen, thorax, muscle fascia (e.g. in the abdominalwall), subcutaneously, or at any other suitable location. The implantedenergy-transforming device 302 is adapted to receive wireless energy Etransmitted from the external source of energy 304 a provided in anexternal energy-transmission device 304 located outside the patient'sskin 305 in the vicinity of the implanted energy-transforming device302.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal source of energy 304 a and an adjacent secondary coil arrangedin the implanted energy-transforming device 302. When an electriccurrent is fed through the primary coil, energy in the form of a voltageis induced in the secondary coil which can be used to power theimplanted energy consuming components of the apparatus, e.g. afterstoring the incoming energy in an implanted source of energy, such as arechargeable battery or a capacitor. However, the present invention isgenerally not limited to any particular energy transfer technique, TETdevices or energy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 304 b that controls the externalsource of energy 304 a based on the determined energy balance toregulate the amount of transferred energy. In order to transfer thecorrect amount of energy, the energy balance and the required amount ofenergy is determined by means of a determination device including animplanted internal control unit 315 connected between the switch 326 andthe constriction/stimulation unit 301. The internal control unit 315 maythus be arranged to receive various measurements obtained by suitablesensors or the like, not shown, measuring certain characteristics of theconstriction/stimulation unit 301, somehow reflecting the requiredamount of energy needed for proper operation of theconstriction/stimulation unit 301. Moreover, the current condition ofthe patient may also be detected by means of suitable measuring devicesor sensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the constriction/stimulation unit 301, such aspower consumption, operational mode and temperature, as well as thepatient's condition reflected by parameters such as: body temperature,blood pressure, heartbeats and breathing. Other kinds of physicalparameters of the patient and functional parameters of the device aredescribed elsewhere.

Furthermore, a source of energy in the form of an accumulator 316 mayoptionally be connected to the implanted energy-transforming device 302via the control unit 315 for accumulating received energy for later useby the constriction/stimulation unit 301. Alternatively or additionally,characteristics of such an accumulator, also reflecting the requiredamount of energy, may be measured as well. The accumulator may bereplaced by a rechargeable battery, and the measured characteristics maybe related to the current state of the battery, any electrical parametersuch as energy consumption voltage, temperature, etc. In order toprovide sufficient voltage and current to the constriction/stimulationunit 301, and also to avoid excessive heating, it is clearly understoodthat the battery should be charged optimally by receiving a correctamount of energy from the implanted energy-transforming device 302, i.e.not too little or too much. The accumulator may also be a capacitor withcorresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 315. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 315 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus, or the patient, or an Implanted source ofenergy if used, or any combination thereof. The internal control unit315 is further connected to an internal signal transmitter 327, arrangedto transmit a control signal reflecting the determined required amountof energy, to an external signal receiver 304 c connected to theexternal control unit 304 b. The amount of energy transmitted from theexternal source of energy 304 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 304 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 304 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 304 b, thus integrating the above-describedfunction of the internal control unit 315 in the external control unit304 b. In that case, the internal control unit 315 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 327 which sends the measurements over to the external signalreceiver 304 c and the external control unit 304 b. The energy balanceand the currently required amount of energy can then be determined bythe external control unit 304 b based on those sensor measurements.

Hence, the present solution according to the arrangement of FIG. 56employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted source of energy or the like. The different parametersdiscussed above would thus be used if relevant and needed and then as atool for determining the actual energy balance. However, such parametersmay also be needed per se for any actions taken internally tospecifically operate the apparatus.

The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 327 and the externalsignal receiver 304 c may be integrated in the implantedenergy-transforming device 302 and the external source of energy 304 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 17, the switch 326is either separate and controlled by the internal control unit 315, orintegrated in the internal control unit 315. It should be understoodthat the switch 326 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 56 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 315 of the determination device.A control signal reflecting the required amount of energy is alsocreated by the internal control unit 315, and the control signal istransmitted from the internal signal transmitter 327 to the externalsignal receiver 304 c. Alternatively, the energy balance can bedetermined by the external control unit 304 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external source of energy 304 a can then be regulatedby the external control unit 304 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external source of energy 304 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics. This system may also be used to obtain informationabout the coupling factors between the coils in a TET system even tocalibrate the system both to find an optimal place for the external coilin relation to the internal coil and to optimize energy transfer. Simplycomparing in this case the amount of energy transferred with the amountof energy received. For example if the external coil is moved thecoupling factor may vary and correctly displayed movements could causethe external coil to find the optimal place for energy transfer.Preferably, the external coil is adapted to calibrate the amount oftransferred energy to achieve the feedback information in thedetermination device, before the coupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 57, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 57,wherein an external switch 326 is interconnected between the externalsource of energy 304 a and an operation device, such as an electricmotor 307 operating the constriction/stimulation unit 301. An externalcontrol unit 304 b controls the operation of the external switch 326 toeffect proper operation of the constriction/stimulation unit 301.

FIG. 58 illustrates different embodiments for how received energy can besupplied to and used by the constriction/stimulation unit 301. Similarto the example of FIG. 56, an internal energy receiver 302 receiveswireless energy E from an external source of energy 304 a which iscontrolled by a transmission control unit 304 b. The internal energyreceiver 302 may comprise a constant voltage circuit, indicated as adashed box “constant V” in FIG. 58, for supplying energy at constantvoltage to the constriction/stimulation unit 301. The internal energyreceiver 302 may further comprise a constant current circuit, indicatedas a dashed box “constant C” in the figure, for supplying energy atconstant current to the constriction/stimulation unit 301.

The constriction/stimulation unit 301 comprises an energy consuming part301 a, which may be a motor, pump, restriction device, or any othermedical appliance that requires energy for its electrical operation. Theconstriction/stimulation unit 301 may further comprise an energy storagedevice 301 b for storing energy supplied from the internal energyreceiver 302. Thus, the supplied energy may be directly consumed by theenergy consuming part 301 a, or stored by the energy storage device 301b, or the supplied energy may be partly consumed and partly stored. Theconstriction/stimulation unit 301 may further comprise an energystabilizing unit 301 c for stabilizing the energy supplied from theinternal energy receiver 302. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 302 may further beaccumulated and/or stabilized by a separate energy stabilizing unit 328located outside the constriction/stimulation unit 301, before beingconsumed and/or stored by the constriction/stimulation unit 301.Alternatively, the energy stabilizing unit 328 may be integrated in theinternal energy receiver 302. In either case, the energy stabilizingunit 328 may comprise a constant voltage circuit and/or a constantcurrent circuit.

It should be noted that FIG. 56 and FIG. 58 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 59 schematically shows an energy balance measuring circuit of oneof the proposed designs of the apparatus for controlling transmission ofwireless energy, or energy balance. The circuit has an output signalcentered on 2.5V and proportionally related to the energy imbalance. Thederivative of this signal shows if the value goes up and down and howfast such a change takes place. If the amount of received energy islower than the energy used by implanted components of the apparatus,more energy is transferred and thus charged into the source of energy.The output signal from the circuit is typically fed to an A/D converterand converted into a digital format. The digital information can then besent to the external energy-transmission device allowing it to adjustthe level of the transmitted energy. Another possibility is to have acompletely analog system that uses comparators comparing the energybalance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 59 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 59; the transmitting partsof the system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 20and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 59 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Intestinal Dysfunction

FIG. 60A illustrates the embodiment of FIG. 2 applied on the smallintestines 31 of a colostomy patient having a stoma opening in theabdomen. The clamping elements 5, 6 of the constriction device 2constrict the small intestines 31 and the stimulation device 3 isenergized to close the intestinal passageway. (For the sake of clarity,the housing is not shown and the clamping elements 5, 6 areexaggerated.) In this embodiment, the control device includes anexternal control unit in the form of a hand-held wireless remote control32A and an implanted internal control unit 33, which may include amicroprocessor, for controlling the constriction and stimulationdevices. There is an external energy transmitter 32A that transmitswireless energy. The remote control 32A and the energy transmitter 32Bmay be separate devices, as shown in FIG. 60A, or may be integrated in asingle hand-held device. The remote control 32A is operable by thepatient to control the internal control unit 33 to switch on and off theconstriction device and/or the stimulation device. Alternatively,however, the remote control 32A may be replaced by a subcutaneouslyimplanted push button that is manually switched by the patient between“on” and“off”. Such a manually operable push button may also be providedin combination with the remote control 32A as an emergency button toallow the patient to stop the operation of the apparatus in case ofemergency or malfunction.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, also works as on energy receiver, i.e., for transformingwireless energy transmitted by the external energy transmitter 32B intoelectric energy and charging the implanted source of energy 35(rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the pressure in the intestines, or a parameter that relates to thepressure in the intestines, wherein the internal control unit 33controls the constriction device 2 and/or the electrical elements 7 ofthe stimulation device 3 in response to signals from the sensor 36. Inthis embodiment the sensor 36 is a pressure sensor, wherein the internalcontrol unit 33 controls the constriction device and/or stimulationdevice to change the constriction of the patient's intestines 31 inresponse to the pressure sensor 36 sensing a predetermined value ofmeasured pressure. For example, the control unit 33 may control theconstriction device and/or stimulation device to increase theconstriction of the patient's intestines 31 in response to the pressuresensor sensing an increased pressure. Alternatively or in combination,the remote control 32 controls the constriction device and/orstimulation device in response to signals from the sensor 36, in thesame manner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36. When the patient's attention is taken bysuch an indication indicating an increased pressure exceeding athreshold value, he or she may use the remote control to control theconstriction device and stimulation device to pump intestinal contentsthrough the patient's stoma.

FIG. 60B shows an embodiment which is similar to the embodiment of FIG.60A except that the constriction device is applied on the smallintestines of a colostomy patient having the small intestines surgicallyconnected to the patient's anus.

Of course, the constriction device 2 shown in FIGS. 60A and 60B may bereplaced by any one of the constriction devices described in the variousembodiments of the present invention, where applicable.

Urinary Dysfunction

FIG. 61A illustrates the embodiment of FIG. 2 applied on the urethra 31of a urinary stress and overflow incontinent patient with the clampingelements 5, 6 of the constriction device 2 constricting the urethra 31and the stimulation device 3 energized to close the urinary passageway.(For the sake of clarity, the housing is not shown and the clampingelements 5, 6 are exaggerated.) In this embodiment, a control deviceincludes an external control unit in the form of a hand-held wirelessremote control 32, and an implanted internal control unit 33, which mayinclude a microprocessor, for controlling the constriction andstimulation devices. The remote control 32 is operable by the patient tocontrol the internal control unit 33 to switch on and off theconstriction device and/or the stimulation device. Alternatively,however, the remote control 32 may be replaced by a subcutaneouslyimplanted push button that is manually switched by the patient between“on” and “off”. Such a manually operable push button may also beprovided in combination with the remote control 32 as an emergencybutton to allow the patient to stop the operation of the apparatus incase of emergency or malfunction.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, also works as en energy receiver, i.e., for transformingwireless energy into electric energy and charging the implanted sourceof energy 35 (rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the pressure in the bladder, or a parameter that relates to thepressure in the bladder, wherein the internal control unit 33 controlsthe constriction device 2 and/or the stimulation device 3 in response tosignals from the sensor 36. In this embodiment the sensor 36 is apressure sensor, wherein the internal control unit 33 controls theconstriction device and/or stimulation device to change the constrictionof the patient's urethra 31 in response to the pressure sensor 36sensing a predetermined value of measured pressure. For example, thecontrol unit 33 may control the constriction device and/or stimulationdevice to increase the constriction of the patient's urethra 31 inresponse to the pressure sensor sensing an increased pressure.Alternatively or in combination, the remote control 32 controls theconstriction device and/or stimulation device in response to signalsfrom the sensor 36, in the same manner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36. When the patient's attention is taken bysuch an indication indicating an increased pressure exceeding athreshold value, or when the patient desires to urinate, he or she mayuse the remote control to control the constriction device andstimulation device to pump urine through the urethra.

The embodiment of FIG. 61B is similar to that of FIG. 61A, except thatthe constriction device is applied to an urether 37 instead of theurethra. This embodiment is in other aspects similar or identical to theembodiment described above with reference to FIG. 61A. It will beappreciated that more than one constriction device can be used, e.g.,one constriction device on each of the two ureters.

FIG. 61C illustrates a constriction device 68 similar to the embodimentof FIG. 27 applied on the urinary bladder of a patient suffering fromurinary dysfunction, i.e., disability to empty the bladder. The clampingelements 69 of the constriction device 68 are positioned on differentsides of the bladder. In this embodiment, the control device includes anexternal control unit in the form of a hand-held wireless remote control32A and an implanted internal control unit 33, which may include amicroprocessor 33A, for controlling the constriction and stimulationdevices. There is an external energy transmitter 32A that transmitswireless energy. The remote control 32A and the energy transmitter 32Bmay be separate devices, as shown in FIG. 61C, or may be integrated in asingle hand-held device. The remote control 32A is operable by thepatient to control the internal control unit 33 to switch on and off theconstriction device and/or the stimulation device. The internal controlunit 33 also includes a push button 33B that can be used by the patientto manually switch “on” and “off” the operation of the constrictionand/or stimulation devices. The button also serves as an emergencybutton to allow the patient to stop the operation of the apparatus incase of emergency or malfunction.

The internal control unit 33 controls a hydraulic operation device 34 tomove the clamping elements 69. An injection port 33F integrated in thepush button 33B is provided to calibrate the amount of hydraulic fluidin hydraulic components of the hydraulic operation device. The internalcontrol unit 33 also includes a source of energy 33C, such as arechargeable battery, for powering the operation device 34, and anenergy receiver 33D for transforming wireless energy transmitted by theexternal energy transmitter 32B into electric energy and charging theimplanted source of energy 33C (rechargeable battery) with the electricenergy.

An implanted sensor 36 applied on the constriction device (here on theclamping element 69) senses a physical parameter of the patient, such asthe pressure in the bladder, or a parameter that relates to the pressurein the bladder, the internal control unit 33 includes a signaltransmitter 33E that sends an alarm signal to the external remotecontrol 32A in response to signals from the sensor 36 indicating apredetermined value of measured pressure.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto received signals such as alarm signals. When the patient's attentionis taken by such an indication indicating an increased pressureexceeding a threshold value, or when the patient desires to urinate, heor she may conveniently use the remote control 32A or the push button33B to activate the operation device 34 to empty the bladder.

The embodiment of FIG. 61D is similar to that of FIG. 61C, except thatthe clamping elements 5, 6 of the constriction device 2 shown in FIG.61A is applied on the urethra 31. The embodiment of FIG. 61D is suitedto treat patients who are incontinent as well as disabled to empty thebladder.

The skilled person understands that the embodiments of FIGS. 61A-61Dcould be combined in many different ways as desired. For example, asshown in FIG. 14B, another constriction device may be applied on thepatient's urether 37 in the embodiment of FIG. 61C.

Obesity

FIG. 62A schematically illustrates the stomach 31 of an obese patienttreated by AGB (Adjustable Gastric Banding). A constriction/stimulationunit CSD designed as a hydraulically adjustable clamp (similar to theunit 68 shown in FIG. 27) is applied around the stomach 31 Theclamp-shaped unit CSD clamps the stomach 31, so that the stomach isflattened, except at the middle of the stomach, where the clamp-shapedunit CSD is enlarged to form an opening defined by two opposedsemi-circles of the clamp-shaped unit CSD, see FIG. 62B. This openingdefined by said semi-circles permits a food passageway to form in thestomach.

There is a wireless remote control 32A and an implanted internal controlunit 33, which may include a microprocessor 33A, for controlling theunit CSD, and an external energy transmitter 32A that transmits wirelessenergy. In this embodiment the remote control 32A and the energytransmitter 32B are separate devices. However, they may be integrated ina single hand-held device. The remote control 32 is operable by a nurseor doctor to program the microprocessor to properly control theconstriction/stimulation unit CSD to suit the individual patients. Inaddition, the constriction/stimulation unit CSD may be controlled by asubcutaneously implanted push button that can be used by the patient totemporarily switch off the operation of the constriction/stimulationunit CSD in case of emergency, or malfunction of the apparatus.

An injection port 33F integrated in the push button 33B is provided tocalibrate the amount of hydraulic fluid in hydraulic components of theadjustable hydraulic clamp of unit CSD. The internal control unit 33also includes a source of energy 33C, such as a rechargeable battery,for powering the unit CSD, and an energy receiver 33D for transformingwireless energy transmitted by the external energy transmitter 32B intoelectric energy and charging the implanted source of energy 33C(rechargeable battery) with the electric energy.

An implanted sensor (not shown) senses a physical parameter of thepatient, such as the pressure in the stomach, or a parameter thatrelates to the pressure in the stomach. The internal control unit 33controls the constriction/stimulation unit CSD to reduce or even closethe food passageway in response to signals from the sensor indicatingflow of food into the stomach, i.e., when the patient has started toeat. After the lapse of a preset period of time, when the patient feelssatiety, the internal control unit 33 controls theconstriction/stimulation device CSD to open up the food passageway toallow food collected in the upper part of the stomach to pass throughthe food passageway. Alternatively or in combination, the remote control32 controls the constriction/stimulation unit CSD in response to signalsfrom the sensor, in the same manner as the internal control unit 33.

The internal control unit 33 may include a signal transmitter that cansend an alarm signal to the external remote control 32 in response tosignals from the sensor 36 indicating a harmful high pressure in thestomach. The remote control 32 may be equipped with means for producingan indication, such as a sound signal or displayed information, inresponse to received alarm signals. When the patient's attention istaken by such an alarm signal, he or she may use the push buttonmentioned above to temporarily switch off the operation of theconstriction/stimulation unit CSD to fully open up the food passageway.

FIG. 63 schematically illustrates the stomach 31 of an obese patienttreated by VBG (Vertical Banded Gastroplasty), which is a recognizedtype of bariatric surgery. VBG is currently normally performed withlaparoscopic surgery, introducing a camera and other instruments intothe abdominal cavity. The stomach is then normally stapled by theinstruments in two steps to achieve a stapled circular opening rightthrough both layers of the stomach followed by a vertical stapling of atleast two vertical rows of staples. The staples compartmentalize thestomach 31 into a smaller proximal compartment 31A adjacent theoesophagus 32 and a larger distal compartment 31B, wherein the smallerproximal compartment 31A communicates with the larger distal compartment31B through a relatively small outlet opening. The smaller proximalcompartment 31A forms a prolongation of the oesophagus 32 at an upperpart of the stomach. In this case the stomach 31 has been divided inbetween the vertical rows of staples 32.

A constriction/stimulation unit CSD in the form of a sleeve is appliedon the stomach around the “prolongation of the oesophagus”. Of course,the constriction/stimulation unit CSD may be selected from any one ofthe various constriction and stimulation devices here disclosed. Acontrol device includes an external control unit in the form of ahand-held wireless remote control 33 and a subcutaneously implantedinternal control unit 34, which may include a microprocessor 34A, forcontrolling and programming the operation of theconstriction/stimulation unit CSD. There is an external energytransmitter 35 that transmits wireless energy. The remote control 33 andthe energy transmitter 35 may be separate devices, as shown in FIG. 63,or may be integrated in a single hand-held device. The remote control 33is operable by a nurse or doctor to program the microprocessor 34A toproperty control the constriction/stimulation unit CSD to suit theindividual patients. The internal control unit 34 also includes anemergency push button 34B that can be used by the patient to temporarilyswitch off the operation of the constriction/stimulation unit CSD incase of emergency, or malfunction of the apparatus. Where theconstriction device of the constriction/stimulation unit CSD ishydraulically operated, an injection port 34F is provided integrated inthe push button 34B to calibrate the amount of hydraulic fluid inhydraulic components of the hydraulic system serving the constrictiondevice.

The internal control unit 34 also Includes a source of energy 34C, suchas a rechargeable battery, for powering the constriction/stimulationunit CSD, and an energy receiver 34D for transforming wireless energytransmitted by the external energy transmitter 35 into electric energyand charging the implanted source of energy 34C (rechargeable battery)with the electric energy.

An implanted sensor 36 connected to the internal control unit 34 andapplied on the smaller proximal compartment 31A senses a physicalparameter of the patient, such as the pressure in the compartment 31A,or a parameter that relates to the pressure in the compartment 31A. Theinternal control unit 34 controls the constriction/stimulation unit CSDto reduce or even close the food passageway extending from the smallerproximal compartment 31A to the larger distal compartment 31B inresponse to signals from the sensor 36 indicating flow of food into thesmaller compartment, i.e., when the patient has started to eat. Afterthe lapse of a preset period of time, when the patient feels satiety,the internal control unit 34 controls the constriction/stimulation unitCSD to open up the food passageway to allow food collected in thesmaller compartment 31A to pass into the larger compartment 31B.Alternatively or in combination, the remote control 33 controls theconstriction/stimulation unit CSD in response to signals from the sensor36, in the same manner as the internal control unit 34.

The internal control unit 34 also includes a signal transmitter 34E thatcan send an alarm signal to the external remote control 33 in responseto signals from the sensor 36 indicating a harmful high pressure in thesmaller apartment 31A. The remote control 33 may be equipped with meansfor producing an indication, such as a sound signal or displayedinformation, in response to received alarm signals. When the patient'sattention is taken by such an alarm signal, he or she may use the pushbutton 34B to temporarily switch off the operation of theconstriction/stimulation unit CSD to fully open up the food passageway.

Male Sexual Dysfunction

FIG. 64A illustrates the apparatus of the invention applied on a maleimpotent patient. A constriction/stimulation unit CSD in the form of asleeve is applied around the corpus cavernosum CV In the penile portion31 of the patient. Of course, the constriction/stimulation unit CSD maybe selected from any one of the various constriction and stimulationdevices here disclosed. A control device includes an external controlunit in the form of a hand-held wireless remote control 33 and asubcutaneously implanted internal control unit 34, which may include amicroprocessor 34A, for controlling and programming the operation of theconstriction/stimulation unit CSD. There is an external energytransmitter 35 that transmits wireless energy. The remote control 33 andthe energy transmitter 35 may be separate devices, as shown in FIG. 64A,or may be integrated in a single hand-held device. The remote control 33is operable to program the microprocessor 34A to properly control theconstriction/stimulation unit CSD to suit the individual patients. Theinternal control unit 34 also includes an emergency push button 34B thatcan be used by the patient to temporarily switch off the operation ofthe constriction/stimulation unit CSD in case of malfunction of theapparatus. Where the constriction device of the constriction/stimulationunit CSD is hydraulically operated, an injection port 34F is providedintegrated in the push button 34B to calibrate the amount of hydraulicfluid in hydraulic components of the hydraulic system serving theconstriction device.

The internal control unit 34 also includes a source of energy 34C, suchas a rechargeable battery, for powering the constriction/stimulationunit CSD, and an energy receiver 34D for transforming wireless energytransmitted by the external energy transmitter 35 into electric energyand charging the implanted source of energy 34C (rechargeable battery)with the electric energy.

An implanted sensor 36 connected to the internal control unit 34 andapplied on the penile portion 31 senses a physical parameter of thepatient, such as the pressure in the penile portion 31, or a parameterthat relates to the pressure in the penile portion 31. The internalcontrol unit 34 controls the constriction/stimulation unit CSD toincrease or decrease the restriction of the blood flow leaving the penisin response to signals from the sensor 36. When the control unit 34receives signals from the sensor indicating a pressure that exceeds apredetermined high pressure in the penile portion as a result ofejaculation, the internal control unit 34 controls theconstriction/stimulation unit CSD to release the penile portion torestore the exit penile blood flow. Alternatively or in combination, theremote control 33 controls the constriction/stimulation unit CSD inresponse to signals from the sensor 36, in the same manner as theinternal control unit 34.

The internal control unit 34 also includes a signal transmitter 34E thatcan send an alarm signal to the external remote control 33 in responseto signals from the sensor 36 indicating a too high pressure in thepenile portion 31 that can be harmful to the patient. The remote control33 may be equipped with means for producing an indication, such as asound signal or displayed information, in response to received alarmsignals. When the patient's attention is taken by such an alarm signal,he may use the push button 34B to quickly switch off the operation ofthe constriction/stimulation unit CSD to fully release the penileportion.

FIG. 64B shows an embodiment which is similar to the embodiment of FIG.64A except that the apparatus includes two constriction/stimulationunits CSD which are applied around respective exit veins from thepatient's penis.

Of course, the constriction and stimulation devices of theconstriction/stimulation units shown in FIGS. 64A and 64B may bereplaced by any one of the constriction and stimulation devicesdescribed in the various embodiments of the present invention.

FIG. 65A illustrates the apparatus of the invention implanted in afemale patient. A constriction/stimulation unit CSD of the apparatus isapplied on a erectile tissue portion 31 of the patient. Of course, theconstriction/stimulation unit CSD may be selected from any one of thevarious constriction and stimulation devices here disclosed. A controldevice includes an external control unit in the form of a hand-heldwireless remote control 33 and a subcutaneously implanted internalcontrol unit 34 that controls the operation of theconstriction/stimulation unit CSD.

FIG. 65B illustrates in more detail the components of the apparatusshown in FIG. 65A. Thus, there are two constriction/stimulation unitsCSD applied on respective exit veins of the erectile tissue portion 31of the patient. The implanted internal control unit 34 includes amicroprocessor 34A for controlling and programming the operation of theconstriction/stimulation unit CSD. There is an external energytransmitter 35 that transmits wireless energy. The remote control 33 andthe energy transmitter 35 may be separate devices, as shown in FIG. 65B,or may be integrated in a single hand-held device. The remote control 33is operable to program the microprocessor 34A to properly control theconstriction/stimulation unit CSD to suit the individual patients. Theinternal control unit 34 also includes an emergency push button 34B thatcan be used by the patient to temporarily switch off the operation ofthe constriction/stimulation unit CSD in case of malfunction of theapparatus. Where the constriction device of the constriction/stimulationunit CSD is hydraulically operated, an injection port 34F issubcutaneously implanted to calibrate the amount of hydraulic fluid inhydraulic components of the hydraulic system serving the constrictiondevice of the constriction/stimulation unit CSD.

The internal control unit 34 also includes a source of energy 34C, suchas a rechargeable battery, for powering the constriction/stimulationunit CSD, and an energy receiver 34D for transforming wireless energytransmitted by the external energy transmitter 35 into electric energyand charging the implanted source of energy 34C (rechargeable battery)with the electric energy.

An implanted sensor 36 connected to the Internal control unit 34 andapplied on the erectile tissue portion 31 senses a physical parameter ofthe patient, such as the pressure in the erectile tissue portion 31, ora parameter that relates to the pressure in the erectile tissue portion31. The internal control unit 34 controls the constriction/stimulationunit CSD to increase or decrease the restriction of the venous bloodflow leaving the erectile tissue in response to signals from the sensor36. When the control unit 34 receives signals from the sensor indicatinga pressure that exceeds a predetermined high pressure in the erectiletissue portion as a result of orgasm, the internal control unit 34controls the constriction/stimulation unit CSD to release the erectiletissue portion to restore the exit erectile blood flow. Alternatively orin combination, the remote control 33 controls theconstriction/stimulation unit CSD in response to signals from the sensor36, in the same manner as the internal control unit 34.

The internal control unit 34 also includes a signal transmitter 34E thatcan send an alarm signal to the external remote control 33 in responseto signals from the sensor 36 indicating a too high pressure in theerectile tissue portion 31 that can be harmful to the patient. Theremote control 33 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto received alarm signals. When the patient's attention is taken by suchan alarm signal, she may use the push button 34B to quickly switch offthe operation of the constriction/stimulation unit CSD to fully releasethe erectile tissue portion.

FIG. 65C shows an embodiment which is similar to the embodiment of FIG.65B except that the two constriction/stimulation units CSD are appliedaround respective corpora cavernosa CC of the patient's erectile tissue.

Of course, the constriction and stimulation devices of theconstriction/stimulation units shown in FIGS. 65A, 65B and 65C may bereplaced by any one of the constriction and stimulation devicesdescribed in the various embodiments of the present invention.

Egg Movement Control

FIG. 66 illustrates the embodiment of FIG. 2 applied on the uterinetubes 31 of a patient. The clamping elements 5, 6 of the constrictiondevice 2 constrict the uterine tubes 31 and the stimulation device 3 isenergized to close the uterine tube. (For the sake of clarity, thehousing is not shown and the clamping elements 5, 6 are exaggerated.) Inthis embodiment, a control device includes an external control unit inthe form of a hand-held wireless remote control 32, and an implantedinternal control unit 33, which may include a microprocessor, forcontrolling the constriction and stimulation devices. The remote control32 is operable by the patient to control the internal control unit 33 toswitch on and off the constriction device and/or the stimulation device.Alternatively, however, the remote control 32 may be replaced by asubcutaneously implanted push button that is manually switched by thepatient between “on” and“off”. Such a manually operable push button mayalso be provided in combination with the remote control 32 as anemergency button to allow the patient to stop the operation of theapparatus in case of emergency or malfunction.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, also works as en energy receiver, i.e., for transformingwireless energy into electric energy and charging the implanted sourceof energy 35 (rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the pressure in the uterine tubes, or a parameter that relates to thepressure in the uterine tubes, wherein the internal control unit 33controls the constriction device 2 and/or the stimulation device 3 inresponse to signals from the sensor 36. In this embodiment the sensor 36is a pressure sensor, wherein the internal control unit 33 controls theconstriction device and/or stimulation device to change the constrictionof the patient's uterine tubes 31 in response to the pressure sensor 36sensing a predetermined value of measured pressure. For example, thecontrol unit 33 may control the constriction device and/or stimulationdevice to increase the constriction of the patient's uterine tubes 31 inresponse to the pressure sensor sensing an increased pressure.Alternatively or in combination, the remote control 32 controls theconstriction device and/or stimulation device in response to signalsfrom the sensor 36, in the same manner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36. When the patient's attention is taken bysuch an indication indicating an increased pressure exceeding athreshold value she may use the remote control to control theconstriction device and stimulation device to pump eggs through thepatients uterine tubes.

Of course, the constriction device 2 shown in FIG. 66 may be replaced byany one of the constriction devices described in the various embodimentsof the present invention, where applicable.

Sperm Movement Control

FIG. 67 illustrates the embodiment of FIG. 2 applied on the uterine tubeof a patient. The clamping elements 5, 6 of the constriction device 2constrict the uterine tubes 31 and the stimulation device 3 is energizedto close the uterine tube. (For the sake of clarity, the housing is notshown and the clamping elements 5, 6 are exaggerated.) In thisembodiment, a control device includes an external control unit in theform of a hand-held wireless remote control 32, and an implantedinternal control unit 33, which may include a microprocessor, forcontrolling the constriction and stimulation devices. The remote control32 is operable by the patient to control the internal control unit 33 toswitch on and off the constriction device and/or the stimulation device.Alternatively, however, the remote control 32 may be replaced by asubcutaneously implanted push button that is manually switched by thepatient between “on” and “off”. Such a manually operable push button mayalso be provided in combination with the remote control 32 as anemergency button to allow the patient to stop the operation of theapparatus in case of emergency or malfunction.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, also works as en energy receiver, i.e., for transformingwireless energy into electric energy and charging the implanted sourceof energy 35 (rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the pressure in the uterine tubes, or a parameter that relates to thepressure in the uterine tubes, wherein the internal control unit 33controls the constriction device 2 and/or the stimulation device 3 inresponse to signals from the sensor 36. In this embodiment the sensor 36is a pressure sensor, wherein the internal control unit 33 controls theconstriction device and/or stimulation device to change the constrictionof the patient's intestines 31 in response to the pressure sensor 36sensing a predetermined value of measured pressure. For example, thecontrol unit 33 may control the constriction device and/or stimulationdevice to increase the constriction of the patient's uterine tubes 31 inresponse to the pressure sensor sensing an increased pressure.Alternatively or in combination, the remote control 32 controls theconstriction device and/or stimulation device in response to signalsfrom the sensor 36, in the same manner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36. When the patient's attention is taken bysuch an indication indicating an increased pressure exceeding athreshold value, he or she may use the remote control to control theconstriction device and stimulation device to pump sperms through herthe patient's uterine tubes towards the ovary, if pregnancy is desired.Otherwise, she may control the pump to. If pregnacy wants to be achievedor pump in the opposite direction to avoid pregnancy.

Of course, the constriction device 2 shown in FIG. 67 may be replaced byany one of the constriction devices described in the various embodimentsof the present invention, where applicable.

A constriction device can be arranged to delay the movement of thesperms towards the egg for a predetermined amount of time in order toavoid pregnancy. This can be acheived in many different ways, of whichtwo will be described below.

FIG. 68 is a sectional view through a constriction device 2 adapted torestrict or stop the flow through an uterine tube. The general flowdirection is illustrated by an arrow. The constriction device comprisesan array of constriction elements 2 a-2 m, each arranged to restrict orclose a part of the uterine tube. The constriction device is in an openor non-operative position wherein the flow is uninterrupted

FIG. 69A illustrates the constriction device of FIG. 68 in a firstinterrupting stage, wherein every other constriction element is in aclosed position. A sperm, generally designated 1000, is allowed to enterthe space formed by the first, non-closed constriction element. It isstopped there by the second constriction element, which is in a closedposition. This operative state can remain for a desired period of time,such as one day.

FIG. 69B illustrates the constriction device of FIG. 68 in a secondinterrupting stage, wherein every constriction element that was closedin the first interrupting stage is in an open position and vice versa.The sperm is then allowed to enter the space formed by the second,non-closed constriction element. It is stopped there by the thirdconstriction element, which is in a closed position. This operativestate can remain for a desired period of time, such as one day.

FIG. 69A illustrates the constriction device of FIG. 68 in a thirdinterrupting stage, wherein every other constriction element is in aclosed position, exactly as in the first interrupting stage. The spermshown in FIGS. 69A and 69B, is allowed to enter the space formed by thethird, non-closed constriction element. It is stopped there by thefourth constriction element, which is in a closed position. Thisoperative state can remain for a desired period of time, such as oneday.

Repeating this process, the movement of a sperm can be delayed for adesired period of time until it reaches the other end of theconstriction device. Since the life of a sperm is less than about fivedays, delaying a sperm in this way will ensure that it does not reach anegg in the uterine tube and thereby the constriction device functions toprevent undesired pregnancy. By altering the constricted area of theuterine tube, this will not be harmed like if the same area wereconstricted for a longer period of time.

FIGS. 70A-D show a second embodiment of a constriction device. Thisoperates in a way similar to the first embodiment of a constrictiondevice shown in FIGS. 69A-C. However, in this embodiment, twoconsecutive constriction elements are in an open position at a time whenallowing progress of the sperm.

FIG. 71 A-E disclose one particular embodiment of the invention using asperm pump to pump such sperms up from the uterus into the uterine tube.The principle is simple; more than one restriction device is supplied onthe outside of the uterine tube to restrict the same from the outsidethereof. The restriction device may comprise any one of or a combinationof; a stimulation device, a mechanical or hydraulic restriction device.One first restriction is applied and restricted. At least one furtherrestriction is then applied closer to the ovary. Preferably therestriction applies slowly to not cause any unnecessary movement of anyegg backwards to the ovary, because the uterine tube has an open end atthe ovary end thereof. The further restriction preferably has a longerrestricted area. Thereafter all the restrictions are rapidly releasedcausing suction both from the ovary side and also from the uterussucking up sperm from the uterus and egg from the ovary side. As long asthe restriction is applied slowly and released fast any other way ofapplying the restriction may alternatively work.

FIG. 71A disclose an applied restriction on the uterine side with arestriction device 2. FIG. 71 B-D disclose further applied restrictions.FIG. 71E disclose a rapid release of all the restriction areas at thesame time thus creating a suction of sperm from the uterus side.

It will thus be realized that the above described control of sperms inthe uterine tube is also applicable to eggs moving through a uterinetube.

Blood Flow Control

FIG. 72A illustrates a constriction/stimulation device applied on ablood vessel a patient suffering from pulmonary hypertension. Arestriction device is applied on the pulmonary artery in this case thetrunk as disclosed. The combination of gently constricting andstimulating will cause a restriction to reduce blood pressure. In thisembodiment, the control device includes an external control unit in theform of a hand-held wireless remote control 32A and an implantedinternal control unit 33, which may include a microprocessor 33A, forcontrolling the constriction and stimulation devices. There is anexternal energy transmitter 32A that transmits wireless energy. Theremote control 32A and the energy transmitter 32B may be separatedevices, as shown in FIG. 72, or may be integrated in a single hand-helddevice. The remote control 32A is operable by the patient to control theinternal control unit 33 to switch on and off the constriction deviceand/or the stimulation device. The internal control unit 33 alsoincludes a push button 33B that can be used by the patient to manuallyswitch “on” and “off” the operation of the constriction and/orstimulation devices. The button also serves as an emergency button toallow the patient to stop the operation of the apparatus in case ofemergency or malfunction. Preferably the control unit controls thedevice automatically after input from a sensor.

The internal control unit 33 controls the constriction/stimulationdevice. The internal control unit 33 also includes a source of energy33C, such as a rechargeable battery, for powering the operation device34, and an energy receiver 33D for transforming wireless energytransmitted by the external energy transmitter 32B into electric energyand charging the implanted source of energy 330 (rechargeable battery)with the electric energy.

An implanted sensor 36 applied on the constriction device senses aphysical parameter of the patient, such as the pressure in the vessel,or a parameter that relates to the pressure in the vessel. The internalcontrol unit 33 includes a signal transmitter 33E that sends an alarmsignal to the external remote control 32A in response to signals fromthe sensor 36 indicating a predetermined value of measured pressure.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto received signals such as alarm signals. When the patient's attentionis taken by such an indication indicating an increased pressureexceeding a threshold value, or when the patient desires to urinate, heor she may conveniently use the remote control 32A or the push button33B to activate the operation device 34 to empty the bladder.

A comparison, FIG. 72B illustrates the position of one singleconstriction/stimulation device while FIG. 72C illustrates the positionsof two constriction/stimulation device. To reduce the pressure to thelung the pulmonary artery could be restricted before the bifurcation tothe two lungs or after the same.

Vascular Aneurysm

FIG. 73 shows a general view of a human 100 having a cuff 101 implantedfor treating an aneurysm. In FIG. 73 the treated aneurysm is located onthe aorta in the abdomen close to the Y-bifurcation extending to thelegs. The cuff 101 can be designed in various ways but is generallyformed as an implantable member adapted to be placed in connection witha blood vessel having said vascular aneurysm, and adapted to exert apressure on said aneurysm from the outside of said blood vessel. Inparticular the pressure exerted on the blood vessel is essentiallyuniform from all direction and adapted to hinder the blood vessel toexpand in all directions thereby acting to prevent the blood vessel frombursting. The pressure can in accordance with one embodiment beessentially equal to or lower than the diastolic blood pressure of thetreated patient. The cuff 101 can be made in any suitable material suchas an elastic material adapted for Implantation in a human or mammalbody.

The cuff 101 can exercise the pressure in a number of different ways. Inaccordance with one embodiment of the present invention the pressureapplied on the blood vessel can be mechanical and adjustable by means ofan adjustable screw or a similar means in order to apply a pressure onthe blood vessel. The cuff 101 can also be formed by a spring loadedmember and operated in a suitable manner such as hydraulically orpneumatically

In FIG. 74A a cuff 101 in accordance with one embodiment of the presentinvention is shown in more detail. The cuff 101 comprises a number ofsegments 103 each adjustable and possible to tailor to fit a particularaneurysm 102 of a blood vessel 104 to be treated. Each segment 103 canbe adjusted either as a whole or individually. The segments 103 can becontrolled and adjusted mechanically by an adjustable screw or similaror adapted to be filled with a fluid. For example, the segments can beprovided axially along the blood vessel and also radially along theblood vessel forming a matrix of sub-segments that constitutes the cuff101. In particular one segment can be located above and one below theaneurysm along the blood vessel.

The adjustment can be controlled by an electronic control unit 105adapted to receive and transmit signals from a transmitter/receiver 106located outside the body of a treated patient. The electronic controlunit can also comprise a chargeable battery 111 chargeable from theoutside by an external charger unit 112. The electronic control unit cancomprise an electrical pulse generator 109 for generating electricalpulses as is described in more detail below.

The electronic control unit 105 can further be connected to or comprisea hydraulic pump 110 associated with a reservoir 115 containing of afluid used to regulate the pressure of the cuff 101. The pump is thusadapted to pump the hydraulic fluid in or out from the cuff 101 in orderto adjust the pressure applied in the aneurysm. The control mechanismused for keeping the pressure in the cuff 101 can comprise a pressuretank 117.

The cuff 101 can be shaped in any desirable form to enable treatment ofan aneurysm wherever it is located. In accordance with one embodimentthe cuff 101 is provided with at least one sensor 107 adapted to sensethe pressure from the blood vessel that the cuff is surrounding.

The sensor(s) 107 used to generate a signal indicative of one or manyparameters related to the aneurysm and the device 101 used for treatingthe aneurysm can for example be a gauge sensor. The sensor 107 can beadapted to generate sensor signals used for monitoring parametersincluding but not limited to the pressure in a hydraulic cuff, thepressure of a mechanical cuff, the pressure of a pneumatic cuff, thepressure in a blood vessel, the shape of the blood vessel in particulara parameter related to the diameter of the aneurysm.

By sensing the pressure from the blood vessel the cuff can be controlledto apply a correct pressure on the blood vessel thereby keeping the formof the blood vessel essentially constant. For example the pressure mayvary over time as a result of changes in the wall of the blood vessel ofsurrounding tissue. Also the pressure will change as a function of thephase in which the heart is working. In other words the pressure will bedifferent in a systolic phase as compared to a diastolic phase. By usinga pressure sensor the pressure applied by the cuff 101 can be adapted toreact to changes in the sensed pressure and apply a correspondingcounter pressure. The sensor signals generated by the sensor(s) 107 ofthe cuff can also be used to trigger an alarm in response to the sensorsignal indicating an expansion of the aneurysm. In response to an alarmsignal being generated the cuff can be automatically controlled toexercise a counter pressure on the blood vessel to counter or limit theexpansion of the aneurysm.

In yet another embodiment, electrodes 108 can be provided in the cuff.The electrodes can be connected to the electrical pulse generator, whichis adapted to generate electrical pulses for stimulating the wall of theaneurysm. The purpose of the electrical stimulation is to increase thetonus of the wall of the aneurysm.

In accordance with one embodiment the electrical stimulation device usedfor treating a vascular aneurysm of a human or mammal patient isconnected to electrodes adapted to stimulate the wall of the aneurysm atmultiple stimulation points. The multiple stimulation groups may furtherbe blood vesselized in different stimulation groups which can stimulatedindependently of each other. In accordance with one embodiment theelectrical stimulation is performed with positive and or negativevoltage stimulation pulses. In one embodiment the current used forstimulation of the aneurysm wall is kept essentially constant.

The sequence of electrical pulses used to stimulation the wall of theaneurysm can be applied with a predetermined periodicity having periodsof no stimulation therein between during which periods withoutstimulation the wall of the aneurysm is allowed to rest. The electricalstimulation signal can also be Pulse Width Modulated to control theenergy applied. In accordance with one embodiment the electricalstimulation is applied during the systolic phase to increase the tonusof the wall of the aneurysm. The systolic phase can be detected by thesensors 107 used to sense the pressure of the aneurysm as describedabove.

In accordance with one embodiment the stimulation can be controlled tobe applied with a temporarily increased intensity and position duringemergency situations when the aneurysm is detected to rapidly expands,to limit the expansion of said aneurysm.

The shape of the cuff 101 can as stated above be tailor made to suit thelocation where an aneurysm is to be treated. In FIG. 74C, a cuff 101 isseen from above in a direction aligned with a treated blood vessel. Ascan be seen in FIG. 74C each segment 103 can be sub-divided into anumber of sub segments 103 a, 103 b . . . together forming a closed looparound the treated aneurysm. In case the aneurysm is located in theaorta bifurcation region the cuff 101 can be Y-shaped as is shown inFIG. 74B.

Of course, the constriction device 101 shown in FIGS. 74A-74C may bereplaced by any one of the constriction devices described in the variousembodiments of the present invention, where applicable.

FIG. 75 illustrates a system for treating an aneurysm comprising anapparatus 301 of the present invention placed in the abdomen of apatient 300. An implanted energy-transforming device 302 is adapted tosupply energy consuming components of the apparatus with energy via apower supply line 303. An external energy-transmission device 304 fornon-invasively energizing the apparatus 301 transmits energy by at leastone wireless energy signal. The implanted energy-transforming device 302transforms energy from the wireless energy signal into electric energywhich is supplied via the power supply line 303. The system may alsoinclude a transmitter/receiver 305 located outside the body of a treatedpatient. This transmitter/receiver communicates with an electroniccontrol unit 306 adapted to receive and transmit signals from saidtransmitter/receiver 305. The system can also comprise a chargeablebattery (not shown) chargeable from the outside by an external chargerunit, same or different from the external energy-transmission device304. The system can also comprise an electrical pulse generator (notshown) for generating electrical pulses as is described in more detailbelow.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 304 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 302 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 304 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 301 is operable in response to the energy of the second form.The energy-transforming device 302 may directly power the apparatus withthe second form energy, as the energy-transforming device 302 transformsthe first form energy transmitted by the energy-transmission device 304into the second form energy. The system may further include animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 304 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 304. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 304 may beused to directly power the operation device to create kinetic energy forthe operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 302 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 304 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 302 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 76 illustrates the system of FIG. 75 in the form of a moregeneralized block diagram showing the apparatus 301, theenergy-transforming device 302 powering the apparatus 301 via powersupply line 303, and the external energy-transmission device 304, Thepatient's skin 305, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 77 shows an embodiment of the invention identical to that of FIG.76, except that a reversing device in the form of an electric switch 306operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 301. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 304 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 302transforms the wireless polarized energy into a polarized current foroperating the electric switch 306. When the polarity of the current isshifted by the implanted energy-transforming device 302 the electricswitch 306 reverses the function performed by the apparatus 301.

FIG. 78A shows an embodiment of the invention identical to that of FIG.76, except that an operation device 307 implanted in the patient foroperating the apparatus 301 is provided between the implantedenergy-transforming device 302 and the apparatus 301. This operationdevice can be in the form of a motor 307, such as an electricservomotor. The motor 307 is powered with energy from the implantedenergy-transforming device 302, as the remote control of the externalenergy-transmission device 304 transmits a wireless signal to thereceiver of the implanted energy-transforming device 302.

FIG. 78B shows an embodiment of the invention identical to that of FIG.76, except that it also comprises an operation device is in the form ofan assembly 308 including a motor/pump unit 309 and a fluid reservoir310 is implanted in the patient. In this case the apparatus 301 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 309 from the fluid reservoir 310 through a conduit 311 to theapparatus 301 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 309 back from the apparatus 301 to the fluidreservoir 310 to return the apparatus to a starting position. Theimplanted energy-transforming device 302 transforms wireless energy intoa current, for example a polarized current, for powering the motor/pumpunit 309 via an electric power supply line 312.

Instead of a hydraulically operated apparatus 301, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 302 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 79 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 301, in this case hydraulically operated, and the implantedenergy-transforming device 302, and further comprising a hydraulic fluidreservoir 313, a motor/pump unit 309 and an reversing device in the formof a hydraulic valve shifting device 314, all implanted in the patient.Of course the hydraulic operation could easily be performed by justchanging the pumping direction and the hydraulic valve may therefore beomitted. The remote control may be a device separated from the externalenergy-transmission device or included in the same. The motor of themotor/pump unit 309 is an electric motor. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 304, the implanted energy-transforming device302 powers the motor/pump unit 309 with energy from the energy carriedby the control signal, whereby the motor/pump unit 309 distributeshydraulic fluid between the hydraulic fluid reservoir 313 and theapparatus 301. The remote control of the external energy-transmissiondevice 304 controls the hydraulic valve shifting device 314 to shift thehydraulic fluid flow direction between one direction in which the fluidis pumped by the motor/pump unit 309 from the hydraulic fluid reservoir313 to the apparatus 301 to operate the apparatus, and another oppositedirection in which the fluid is pumped by the motor/pump unit 309 backfrom the apparatus 301 to the hydraulic fluid reservoir 313 to returnthe apparatus to a starting position.

FIG. 80 shows an embodiment of the invention comprising the externalenergy-transmission device 304 with its wireless remote control, theapparatus 301, the implanted energy-transforming device 302, animplanted internal control unit 315 controlled by the wireless remotecontrol of the external energy-transmission device 304, an implantedaccumulator 316 and an implanted capacitor 317. The internal controlunit 315 arranges storage of electric energy received from the implantedenergy-transforming device 302 in the accumulator 316, which suppliesenergy to the apparatus 301. In response to a control signal from thewireless remote control of the external energy-transmission device 304,the internal control unit 315 either releases electric energy from theaccumulator 316 and transfers the released energy via power lines 318and 319, or directly transfers electric energy from the implantedenergy-transforming device 302 via a power line 320, the capacitor 317,which stabilizes the electric current, a power line 321 and the powerline 319, for the operation of the apparatus 301.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 301 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 317 in the embodimentof FIG. 58 may be omitted. In accordance with another alternative, theaccumulator 316 in this embodiment may be omitted.

FIG. 81 shows an embodiment of the invention identical to that of FIG.76, except that a battery 322 for supplying energy for the operation ofthe apparatus 301 and an electric switch 323 for switching the operationof the apparatus 301 also are implanted in the patient. The electricswitch 323 may be controlled by the remote control and may also beoperated by the energy supplied by the implanted energy-transformingdevice 302 to switch from an off mode, in which the battery 322 is notin use, to an on mode, in which the battery 322 supplies energy for theoperation of the apparatus 301.

FIG. 82 shows an embodiment of the invention identical to that of FIG.81, except that an internal control unit 315 controllable by thewireless remote control of the external energy-transmission device 304also is implanted in the patient. In this case, the electric switch 323is operated by the energy supplied by the implanted energy-transformingdevice 302 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the Internal control unit 315 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 315 to releaseelectric energy from the battery 322 for the operation of the apparatus301.

FIG. 83 shows an embodiment of the invention identical to that of FIG.82, except that an accumulator 316 is substituted for the battery 322and the implanted components are interconnected differently. In thiscase, the accumulator 316 stores energy from the implantedenergy-transforming device 302. In response to a control signal from thewireless remote control of the external energy-transmission device 304,the internal control unit 315 controls the electric switch 323 to switchfrom an off mode, in which the accumulator 316 is not in use, to an onmode, in which the accumulator 316 supplies energy for the operation ofthe apparatus 301. The accumulator may be combined with or replaced by acapacitor.

FIG. 84 shows an embodiment of the invention identical to that of FIG.82, except that a battery 322 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 304, the internal control unit 315 controlsthe accumulator 316 to deliver energy for operating the electric switch323 to switch from an off mode, in which the battery 322 is not in use,to an on mode, in which the battery 322 supplies electric energy for theoperation of the apparatus 301.

Alternatively, the electric switch 323 may be operated by energysupplied by the accumulator 316 to switch from an off mode, in which thewireless remote control is prevented from controlling the battery 322 tosupply electric energy and is not in use, to a standby mode, in whichthe wireless remote control is permitted to control the battery 322 tosupply electric energy for the operation of the apparatus 301.

It should be understood that the switch 323 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor. MCU, MCPU. ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 85 shows an embodiment of the invention identical to that of FIG.81, except that a motor 307, a mechanical reversing device in the formof a gear box 324, and an internal control unit 315 for controlling thegear box 324 also are implanted in the patient. The internal controlunit 315 controls the gear box 324 to reverse the function performed bythe apparatus 301 (mechanically operated). Even simpler is to switch thedirection of the motor electronically. The gear box interpreted in itsbroadest embodiment may stand for a servo arrangement saving force forthe operation device in favour of longer stroke to act.

FIG. 86 shows an embodiment of the invention identical to that of FIG.84 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 315 is powered by thebattery 322 when the accumulator 316, suitably a capacitor, activatesthe electric switch 323 to switch to an on mode. When the electricswitch 323 is in its on mode the internal control unit 315 is permittedto control the battery 322 to supply, or not supply, energy for theoperation of the apparatus 301.

FIG. 87 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 301, the internal control unit 315,motor or pump unit 309, and the external energy-transmission device 304including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the internal control unit 315, which in turn controls thevarious implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device325, may be implanted in the patient for sensing a physical parameter ofthe patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 325 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, pressure, volume, diameter, stretc,elongation, extension, movement, bending, elasticity, temperature andflow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 315, or alternatively the external wirelessremote control of the external energy-transmission device 304, maycontrol the apparatus 301 in response to signals from the sensor 325. Atransceiver may be combined with the sensor 325 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 315 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit315 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 301 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 309 and battery 322 for powering themotor/pump unit 309 are implanted, information related to the chargingof the battery 322 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 88 shows an alternative embodiment wherein the apparatus 301 isregulated from outside the patient's body. The system 300 comprises abattery 322 connected to the apparatus 301 via a subcutaneous electricswitch 326. Thus, the regulation of the apparatus 301 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 301 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends Information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 89 shows an alternative embodiment, wherein the system 300comprises a hydraulic fluid reservoir 313 hydraulically connected to theapparatus. Non-invasive regulation is performed by manually pressing thehydraulic reservoir connected to the apparatus. The system may includean external data communicator and an implantable internal datacommunicator communicating with the external data communicator. Theinternal communicator feeds data related to the apparatus or the patientto the external data communicator and/or the external data communicatorfeeds data to the internal data communicator.

Male Contraception

FIG. 90A illustrates the embodiment of FIG. 2 applied on vas deferencefor male contraception. With reference to FIGS. 90A and 90B an apparatusfor male contraception is now described. FIG. 90A shows a restriction ofvas deference (vasa deferentia) with the controller. FIG. 90B depictsonly the restriction devices of the invention. FIG. 90A shows theapparatus having two restriction devices 660A and 660B in arrangementwith the two vas deference to perform restriction of these lumens toprevent sperms from being transported through the vas deference.Restriction devices 660A and 660B operates either to constrict vasdeference, to stimulate vas deference, or the combination thereof. Therestriction devices are operatively connected to the controller 600having a control device 650 that is subcutaneously implanted. Thecontrol device has an energy source 651 for supplying energy consumingparts of the apparatus with energy. The energy source is supplied withwireless energy from an external energizer unit 620. The controllerfurther includes an external remote control unit 630 capable ofcommunicating with the control device 650 and an internal control unit640. The control device further has an external part 652 for includingfunctions needed for external operation such as an injection port forsupply of hydraulic fluid when the constriction is hydraulicallyoperated and an activation/deactivation button for operating therestriction. FIG. 90C shows the same appartus as in FIG. 90B without thecontrol device. FIG. 90D shows a manually operated embodiment of thecontaception device. A manually operable pump 670 located in the scrotumhydraulically operates on the restrction device 660A to restrict vasdeference.

With reference to FIGS. 91A and 918 another embodiment for malecontraception will now be described. FIG. 91A shows a restriction of vasdeference (vasa deferentia) with the controller. FIG. 91B depicts onlythe restriction devices of the invention. FIG. 91A shows the apparatushaving with two restriction devices 660A and 660B in arrangement withthe two vas deference to perform restriction of these lumens to preventfrom that sperms are transported through the vas deference. Restrictiondevices 660A and 660B operates both to constrict and to stimulate vasdeference. The restriction devices are operatively connected to thecontroller 600 having a control device 650 that is subcutaneouslyimplanted. The control device has an energy source 651 for supplyingenergy consuming parts of the apparatus with energy. The energy sourceis supplied with wireless energy from an external energizer unit 620.The controller further includes an external remote control unit 630capable of communicating with the control device 650 and an internalcontrol unit 640. The control device further has an external part 652for including functions needed for external operation such as aninjection port for supply of hydraulic fluid when the constriction ishydraulically operated and an activation/deactivation button foroperating the restriction device.

Gallstones

FIG. 92 illustrates the embodiment of FIG. 2 applied on the common bileduct 31 of a gallstone patient. The clamping elements 5, 6 of theconstriction device 2 constrict the common bile duct 31 and thestimulation device 3 is energized to close the common bile duct. (Forthe sake of clarity, the housing is not shown and the clamping elements5, 6 are exaggerated.) In this embodiment, a control device includes anexternal control unit in the form of a hand-held wireless remote control32. The remote control 32 is operable by the patient to control theinternal control unit 33 to switch on and off the constriction deviceand/or the stimulation device. Alternatively, however, the remotecontrol 32 may be replaced by a subcutaneously implanted push buttonthat is manually switched by the patient between “on” and “off”. Such amanually operable push button may also be provided in combination withthe remote control 32 as an emergency button to allow the patient tostop the operation of the apparatus in case of emergency or malfunction.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, also works as en energy receiver, i.e., for transformingwireless energy into electric energy and charging the implanted sourceof energy 35 (rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the pressure in the intestines, or a parameter that relates to thepressure in the common bile duct, wherein the internal control unit 33controls the constriction device 2 and/or the stimulation device 3 inresponse to signals from the sensor 36. In this embodiment the sensor 36is a pressure sensor, wherein the internal control unit 33 controls theconstriction device and/or stimulation device to change the constrictionof the patient's common bile duct 31 in response to the pressure sensor36 sensing a predetermined value of measured pressure. For example, thecontrol unit 33 may control the constriction device and/or stimulationdevice to increase the constriction of the patient's intestines 31 inresponse to the pressure sensor sensing an increased pressure.Alternatively or in combination, the remote control 32 controls theconstriction device and/or stimulation device in response to signalsfrom the sensor 36, in the same manner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36.

Of course, the constriction device 2 shown in FIG. 92 may be replaced byany one of the devices described in the various embodiments of thepresent invention, where applicable.

Pregnancy Promotion

FIGS. 93A and 93B illustrates a first embodiment of device for treatinga female patient to promote pregnancy applied on the oviducts 31 a, 31 bof a female patient. Clamping elements 5, 6 of a restriction orconstriction device 2 constrict the oviducts 31 a, 31 b. (For the sakeof clarity, the housing is not shown and the clamping elements 5, 6 areexaggerated.) In this embodiment, a control device includes asubcutaneously implanted push button that is manually switched by thepatient between “on” and “off”. Such a manually operable push button mayalso be provided in combination with a remote control as an emergencybutton to allow the patient to stop the operation of the device in caseof emergency or malfunction. Such a remote control will be describedbelow with reference to FIGS. 94A and 94B.

FIGS. 94A and 94B illustrates an alternative embodiment applied on theoviducts 31 a, 31 b of a female patient. The clamping elements 5, 6 ofthe constriction device 2 constrict the oviducts 31 a, 31 b. (For thesake of clarity, the housing is not shown and the clamping elements 5, 6are exaggerated.) In this embodiment, a control device includes anexternal control unit in the form of a hand-held wireless remote control32, and an implanted internal control unit 33, which may include amicroprocessor, for controlling the constriction and stimulationdevices. The remote control 32 is operable by the patient to control theinternal control unit 33 to switch on and off the device.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, may also work as en energy receiver, i.e., for transformingwireless energy into electric energy and charging the implanted sourceof energy 35 (rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the temperature, wherein the internal control unit 33 controls theconstriction device 2 and/or the stimulation device 3 in response tosignals from the sensor 36. In this embodiment the sensor 36 is ahormone level sensor, wherein the internal control unit 33 controls theconstriction device and/or stimulation device to change the constrictionof the patient's oviduct 31 in response to the sensor 36 sensing apredetermined value of measured value. For example, the control unit 33may control the constriction device and/or stimulation device toincrease the constriction of the patient's oviduct 31 in response to thesensor sensing an increased or decreased hormone level. Alternatively orin combination, the remote control 32 controls the constriction deviceand/or a stimulation device in response to signals from the sensor 36,in the same manner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36. When the patient's attention is taken bysuch an indication indicating a release of the oviduct based on saidsensor input. The patient may use the remote control to control theconstriction device or stimulation device to pump eggs through theoviducts of the patient.

Pregnancy Inhibition

FIGS. 95A and 95B illustrates a first embodiment of system for treatinga female patient to prevent pregnancy applied on the oviducts 31 a, 31 bof a female patient. Clamping elements 5, 6 of a restriction orconstriction device 2 constrict the oviducts 31 a, 31 b. (For the sakeof clarity, the housing is not shown and the clamping elements 5, 6 areexaggerated.) In this embodiment, a control device includes asubcutaneously implanted push button that is manually switched by thepatient between “on” and “off”. Such a manually operable push button mayalso be provided in combination with a remote control as an emergencybutton to allow the patient to stop the operation of the system in caseof emergency or malfunction. Such a remote control will be describedbelow with reference to FIGS. 96A and 96B

FIGS. 96A and 96B illustrates an alternative embodiment applied on theoviducts 31 a, 31 b of a female patient. The clamping elements 5, 6 ofthe constriction device 2 constrict the oviducts 31 a, 31 b. (For thesake of clarity, the housing is not shown and the clamping elements 5, 6are exaggerated.) In this embodiment, a control device includes anexternal control unit in the form of a hand-held wireless remote control32, and an implanted internal control unit 33, which may include amicroprocessor, for controlling the constriction and stimulationdevices. The remote control 32 is operable by the patient to control theinternal control unit 33 to switch on and off the restriction device.

The internal control unit 33 controls an implanted operation device 34to move the clamping elements 5, 6. An implanted source of energy 35,such as a rechargeable battery, powers the operation device 34. Theinternal control unit 33, which may be implanted subcutaneously or inthe abdomen, may also work as en energy receiver, i.e., for transformingwireless energy into electric energy and charging the implanted sourceof energy 35 (rechargeable battery) with the electric energy.

An implanted sensor 36 senses a physical parameter of the patient, suchas the temperature, wherein the internal control unit 33 controls theconstriction device 2 and/or the stimulation device 3 in response tosignals from the sensor 36. In this embodiment the sensor 36 is ahormone level sensor, wherein the internal control unit 33 controls theconstriction device and/or stimulation device to change the constrictionof the patient's oviduct 31 in response to the sensor 36 sensing apredetermined value of measured value. For example, the control unit 33may control the constriction device and/or stimulation device toincrease the constriction of the patient's oviduct 31 in response to thesensor sensing an increased or decreased hormone level. Alternatively orin combination, the remote control 32 controls the constriction deviceand/or a stimulation device in response to signals from the sensor 36,in the same manner as the internal control unit 33.

The remote control 32 may be equipped with means for producing anindication, such as a sound signal or displayed information, in responseto signals from the sensor 36. When the patient's attention is taken bysuch an indication indicating a release od the oviduct based on saidsensor input. The patient may use the remote control to control theconstriction device or stimulation device to pump eggs through theoviducts of the patient.

Temporary Male Contraception

FIG. 97A is a schematic view of an apparatus for male contraception asillustrated in FIG. 97B. The apparatus 100 of FIG. 97B shows restrictionof vas deference 200A, 200B (vasa deferentia) downstream the ampulla ofvas deference 220A, 220B. The apparatus thereby is operable totemporarily prevent from reaching urethra and provide time-limitedsterility. The apparatus 100 has a restriction device 120 adapted toconstrict vas deference mechanically or hydraulically and a controldevice 150 for controlling the operation of the restriction device as itis operated with a schematically illustrated operation device 170. Thecontrol device 150 is subcutaneously located and includes an externalpart and an internal part. An energizer unit (energy transmissiondevice) 180 is capable to supply the device with wireless transmittedenergy to an energy transforming device 151 connected to an energysource 152 for supplying energy consuming parts of the apparatus withenergy. An external remote control unit 190 is capable of communicatingwith the control device 150 internal control unit 153 of the controldevice. The external part 150A of the control device 150 includesfunctions needed for external operation such as an injection port forsupply of hydraulic fluid when the constriction is hydraulicallyoperated and an activation/deactivation button for operating therestriction device. The internal part of the control device 1508 caninclude a number of functions needed to control and operate therestrction device 120. In a hydraulically operated restrction device 120the control device 150 can include a pump 154 operable on a reservoirfor hydraulic fluid (not shown), whereby transportation of fluid fromthe reservoir activates the restrction device to restrict vas deferenceand transportation back to the reservoir deactiavates the restrictiondevice to release vas deference. FIG. 97C shows the appartus of FIG. 97Bwithout any control device. The restriction device 120 is of the sametype as in FIG. 1B, but it is here adpated to restrict both vas defernceand the outlet ducts of the seminal vesicles. FIG. 97D shows an appartusof FIG. 97B or 97C with a modified restriction device 120A operatingwith a stimulation device on both vas deference. The stimulation deviceis here represented a by set of electrodes. FIG. 97E shows an appartusof FIG. 97B or 97C with a restriction device comprising a stimulationdevice 120A and a constriction device 120B controlled by the controldevice to restrict both vas derence by their combined actions. In Oneembodiment the constrction device 120B is manually operated with a pumpthat operates on a reservoir to perform a constrction on vas deferencewhile the stimulation device operated by the control device stimulatesvas defernce to obtaining the sperm transport blocking effect. FIG. 97Fshows another variant of the appartus of FIG. 97B, wherein therestriction device 120 includes two constriction devices each adapted toconstrict a vas defernce and an outlet duct of a seminal vesicle,respectively in order to both stop the flow of sperms and seminal fluid.

FIG. 97G illustrates a system for treating a disease comprising anapparatus 10 of the present invention placed in the abdomen of apatient. An implanted energy-transforming device 302 is adapted tosupply energy consuming components of the apparatus with energy via apower supply line 303. An external energy-transmission device 304 fornon-invasively energizing the apparatus 10 transmits energy by at leastone wireless energy signal. The implanted energy-transforming device 302transforms energy from the wireless energy signal into electric energywhich is supplied via the power supply line 303.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 304 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 302 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 304 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 302 may directly power the apparatus withthe second form energy, as the energy-transforming device 302 transformsthe first form energy transmitted by the energy-transmission device 304into the second form energy. The system may further include animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 304 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 304. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 304 may beused to directly power the operation device to create kinetic energy forthe operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 302 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 304 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 302 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

Female Sexual Dysfunction (II)

FIG. 98A schematically illustrates a female patient suffering fromsexual dysfunction having an apparatus 10 implanted and a subcutaneouslyimplanted control device 1002. FIG. 98B is detailed illustration of theapparatus 10. The stimulation device 1001, here illustrated aselectrodes operable to stimulate the veins, is implanted to stimulateveins 204 of the female erectile tissue 205 of the patient. It isconnected to the control device 1002 device trough a power supply line1003. An external energy-transmission device 1004 for energizing theapparatus transmits energy by at least one wireless energy signal. Thesystem can be controlled with a remote control 1099. Also a subcutaneouscontrol switch 1006 can be used to control the apparatus. In oneembodiment a sensor 1044 measures at least one physiological orfunctional parameter. The location of the sensor 1044 is adapted to thecircumstances, e.g. which parameter that should be measured. The controldevice 1002 can comprise at least one item selected from the groupconsisting of; an internal control unit 1041 for communication, aninternal energy source 1042, a sensor control unit 1043, and an energytransforming device for transforming wireless energy from the energytransmission device 1004. If a non-rechargeable battery is used theenergy-transforming device 1044 may be omitted but the other mentioneditems may be used as suitable. In general, any item, or combinations ofitems, described and suited therefore, may be connected to thestimulation device and a senor contacting the female organ via theconnection line 1003. If e.g. the apparatus 10 is electrically operatedit may be suitable to connect it to a source of electrical energy 1042via the connection line 1003 which in this case may be an electricalconduit. The control unit 1041 may be connected to the source ofelectrical energy 1042. FIG. 98B shows the stimulation device asoperating on the veins of corpora cavernosa without the other parts ofthe apparatus. FIG. 98C demonstrates an alternative apparatus whereinthe stimulation device is represented by two different units 1001 eachoperating on corpora cavernosa for its direct stimulation to obtain anengorgement effect.

Female Sexual Dysfunction (III)

FIG. 99A illustrates an apparatus 10 implanted in a female patientsuffering from female sexual dysfunction. An implantedenergy-transforming device 1002 is adapted to supply energy consumingcomponents of the apparatus with energy via a power supply line 1003. Anexternal energy-transmission device 1004 for non-invasively energizingthe apparatus 10 transmits energy by at least one wireless energysignal. The implanted energy-transforming device 1002 transforms energyfrom the wireless energy signal into electric energy which is suppliedvia the power supply line 1003.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 1002 may directly power the apparatuswith the second form energy, as the energy-transforming device 1002transforms the first form energy transmitted by the energy-transmissiondevice 1004 into the second form of energy. The system may furtherinclude an implantable accumulator, wherein the second form of energy isused at least partly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 1004 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 1002 or beseparate.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 99B illustrates in more detail the adjustable restriction device1001, implanted on veins draining female erectile tissue. The energytransforming device 1002 may in another embodiment comprise a battery tosupply energy to the device. The battery supply may of course be placedboth remote to and incorporated in the device. The wirelessenergy-transmission device 1004 will be omitted if only anon-rechargeable battery is used. The system can be controlled with aremote control. In addition to the wireless remote control 1099, asubcutaneous control switch 1006 can be used to control the apparatus.The switch 1006 may in an alternative embodiment comprise a smallhydraulic control reservoir. In such a case an injection port may beprovided specially for calibrating the system with fluid.

The energy-transforming device 1002 may comprise at least one itemselected from the group consisting of; a control unit 1041, a battery1042, a sensor 1043, a motor 1044, a pump 1045, a reservoir 1046. Theitem 1047 may be an injection port. The items being selected dependingon the circumstances, e.g. if the apparatus is electrically,hydraulically, pneumatically or mechanically operated.

Where a non-rechargeable battery is used, the items 1041 to 1047 may beused as suitable, and be connected to the apparatus 10 and sensor 1043as suitable. If e.g. the apparatus 10 is hydraulically operated it maye.g. be suitable to use a control unit 1041, a pump 1045 and/or areservoir 1046.

In general, any item, or combinations of items, described and suitedtherefore, may be connected to the apparatus 10 via the power supplyline 1003. The actual item, or combinations of items, being chosendepending on the circumstances, e.g. if the apparatus 10 iselectrically, hydraulically, pneumatically or mechanically operated.

If e.g. the apparatus 10 is mechanically operated it may be connected toa motor 1044 via the power supply line 1003 which in this case may be awire or bowden cable. A control unit 1041 may be connected to the motor1044.

If e.g. the apparatus 10 is electrically operated it may be suitable toconnect it to a source of electrical energy 1002 or 1042 via the powersupply line 1003 which in this case may be an electrical conduit. Acontrol unit 1041 may be connected to the source of electrical energy1002 or 1042.

A control unit may be provided both for controlling and communicatingwith the implant and out from the body. The control unit may receiveinput from any sensor, specially a pressure sensor. Any type of sensormay be supplied. A motor or pump may be provided depending if the deviceis hydraulically or mechanically restricting. A reservoir may beprovided if the device is hydraulic. The restriction device may compriseany hydraulic device or mechanical device or stimulation device alone orin any combination as described in the present application. Thestimulation device may comprise both thermal stimulation or electricalstimulation. Although the device has specific placements on the drawingsit should be understood that the placement may vary a lot within thefemale genital area, preferable placed in the area of the femaleerectile tissue. The implant preferably includes intelligence in formsof a FPGA or MCU or ASIC or any other circuit, component or memory.

FIG. 99C illustrates the adjustable restriction device 1001, implantedin the female erectile tissue of the patient to constrict the two veinsystems 204 that normally drain the female erectile tissue 205 of blood.More restriction devices may be provided.

FIG. 99D illustrates the adjustable restriction device 1001, implanteddirectly on the female erectile tissue 205 of the patient, for examplethe two corpus cavernosum and/or vestibular bulbs.

Intestinal Disorder

“Artificial Reservoir”

FIG. 100a shows a system according to the present invention, wherein thereservoir 140 is formed by a plurality of bent portions of humanintestine 70, with laterally adjacent sections thereof being cut openalong their mutual contact line and the resulting upper halfs and lowerhalfs thereof being interconnected so as to form a reservoir 140. Theflow control device consists of one exit valve 65 implanted within theintestine 70, and the intestine 70 exits the patients abdominal wall 101through a surgically created stomy 170. An external manually drivensuction pump 110 is used for emptying the reservoir 140, wherein aconduit 111 on the front end of the pump 110 is inserted from outsidethe patient's body into the intestine 70, thereby mechanically urgingthe exit valve 65 to open. Accordingly, the structure of the exit valve65 is resilient so as to close automatically.

FIG. 100b shows an embodiment wherein the reservoir 140 is formed by aplurality of bent portions of human intestine 70, with laterallyadjacent sections thereof being cut open along their mutual contact lineand the resulting upper halfs and lower halfs thereof beinginterconnected so as to form a reservoir 140. The flow control deviceconsists of one exit valve 65 implanted on the outside of the intestine70.

FIG. 101c shows the embodiment wherein the reservoir 140 is formed by aplurality of bent portions of human intestine 70, in a frontal view. Thereservoir is adapted to be emptied by means of electric stimulationdelivered by electrical stimulation electrodes 1050 connected to acontrol unit 1051 by electrical leads 1052. The control unit 1051 isherein adapted to be implanted, and a switch 1053 for operating thecontrol unit could be subcutaneously implanted such that it can beoperated by the patient. The electrodes are according to the embodimentshown adapted to be sequentially activated top-down such that thereservoir intake is closed when the electrode at the top is activated;thereafter the electrodes are activated sequentially to empty thereservoir.

FIG. 101d shows the reservoir adapted to be emptied using electricstimulation according to FIG. 101c , in a top view.

FIG. 101e shows an embodiment wherein the reservoir 140 is formed by aplurality of bent portions of human intestine 70, in a frontal view. Thereservoir is adapted to be emptied by means of a mechanical element 1060being a roller 1060 adapted to roll over the reservoir in the directionfrom the top portion to the bottom portion, compressing the reservoirand thereby emptying the reservoir. The rollers are guided by guiderails 1061 controlling the movement of the rollers 1060. The emptyingdevice is controlled by an implantable control unit 1051 which isconnected to the emptying device by an electrical lead 1052. A switch1053 for operating the control unit could be subcutaneously implantedsuch that it can be operated by the patient.

FIG. 101f shows the reservoir adapted to be emptied using a mechanicalelement 1060 according to FIG. 101e , in a top view.

FIG. 101g shows an embodiment wherein the reservoir 140 is formed by aplurality of bent portions of human intestine 70, in a frontal view. Thereservoir is adapted to be emptied by means of a hydraulic emptyingdevice 1070 comprising an inflatable device adapted to be filled by ahydraulic fluid in the direction from the top portion to the bottomportion, compressing the reservoir and thereby emptying the reservoir.The inflatable device comprises a plurality of sections 1071 adapted tobe sequentially filled by a hydraulic fluid. The hydraulic device 1070is controlled by an implantable control unit 1051 which is connected toa fluid reservoir 1072 comprising a pump by an electrical lead 1052. Thepump is adapted to pump fluid from the fluid reservoir 1072 through aconduit 1073 a into the inflatable device. A switch 1053 for operatingthe control unit could be subcutaneously implanted such that it can beoperated by the patient.

FIG. 101h shows the reservoir adapted to be emptied using a hydraulicdevice 1070 according to FIG. 101g , in a top view.

FIG. 101e shows a variant to FIG. 1. Instead of being implanted insidethe patient's intestine 70, the exit valve 65 makes part of anartificial intestine section 2, one end 4 of which forms the stomyopening 170 and the other end 3 of which is affixed by means of aring-and-bulge connector 15, 30 to the cross-sectional opening of theintestine 70.

FIG. 101b shows an enlarged view of the ring-and-bulge connection 15, 30between the artificial intestine section 2 and the patient's intestine70.

FIGS. 102A and 102B show an alternative to the ring-and-bulge connectionof FIG. 2A. Here, the artificial intestine section 2 comprises a conduitand a flexible sleeve 10 which axially extends and closely fits aroundthe outer surface 6 of the conduit 2. The sleeve 10 is rolled uponitself and can be unrolled such that a part 71 of the intestine 70 islocated intermediate the sleeve 10 and the conduit 2.

FIGS. 103A and 103B show an alternative to the connection in FIGS. 102Aand 102B. Instead of unrolling the sleeve 10, it is simply pulled overthe intestine 71.

FIGS. 103C and 103D show another sleeve connection. Here, the sleeve 10is mounted on the outer surface of the conduit 2 so as be foldable uponitself. By folding the flexible sleeve 10 upon itself, a part 71 of theintestine 70 is located intermediate the folded sleeve 10.

FIGS. 104A and 104B show a combined connection comprising both thefunction of the ring-and-bulge connection and the function of the sleeveconnection of FIGS. 102A and 102B. Combinations of the ring-and-bulgeconnection with the sleeve connections of FIG. 103A, 103B or 103C, 103Dare likewise possible.

FIG. 105 generally shows that the artificial intestine section may beaffixed with both open ends 3, 4 to cross-sectional openings created inthe patient's intestine 70, 80, intended for cases where the downstreamopen end portion of the artificial intestine section is not intended toform a stomy or anus. The artificial intestine section here is shownwithout any internal components and may comprise a reservoir forintestinal contents, one or more valves, a pump and/or any other flowcontrol device. The connection of the open end portions of theartificial intestine section to the patient's intestine is shown in FIG.105 to be made by sleeve connections, here involving a single sleeve 10.

FIG. 106A shows an embodiment with an artificial reservoir 40 connectedto a lateral opening in the patient's intestine wall. An entry valve 42and an exit valve 43 are arranged at the patient's intestine upstreamand downstream of the reservoir 40. A stomy 170 exiting the patient'sabdominal wall 101 has been surgically created from the patient's smallor large intestine. The reservoir 40 is mounted with a pump 41 in acommon housing and the pump 41 and the entry and exit valves 42, 43 arecontrolled by means of a control device, of which a part 91 is implantedinside the patient's body 100. Data are transmitted wirelessly betweenthe external part 90 and the implanted part 91 of the control unit. Inaddition, energy is wirelessly transmitted to an accumulator alsoimplanted in the patient's body and galvanically connected here to thevalves and pump.

FIG. 106B shows the system of FIG. 106A connected to the patient's anusrather than to a surgically created stomy.

FIGS. 107A and 107B show a specific embodiment, wherein the pump 41 andthe reservoir 40 are comprised in a common housing and the pump 41comprises a moveable piston 44 with a front end 45 of the piston 44extending into the reservoir 40 such that a volume of the reservoir 40is reduced upon advancement of the piston 44. The piston 44 is springloaded so as to urge the piston 44 into a normally retracted position.Furthermore, entry and exit valves 42, 43 are provided in thisembodiment, here being realized as flap valves. The flap valves arecontrolled so that one valve is open while the other one is closed.

FIGS. 108A and 108B show a system similar to the one of FIGS. 107A and107B. However, here the entry and exit valves 42, 43 comprise bellows 46acting on the intestine 70 from the outside so as to close the intestine70 by compression. In FIG. 108A the bellows 46 of the exit valve 43 areexpanded to compress the intestine 70 at the downstream side of thereservoir 40, whereas in FIG. 108B the intestine 70 is closed by meansof the bellows 46 of the entry valve 42 upstream of the reservoir 40 sothat the reservoir 40 can be emptied by advancing the piston 44 of thepump 41.

FIG. 109 shows an embodiment schematically, wherein the artificialintestine section 2 by-passes a section of the patient's intestine 70,the intestine 70 being closed by sewing so as to direct intestinalcontent towards the artificial intestine section 2. The enlarged area ofthe artificial intestine section represents any kind of element actingon the intestinal contents within the artificial intestine section, suchas a reservoir, one or more valves, a pump or any other flow controldevice, possibly including a motor, and the like. Furthermore, a battery92 implantable in the patient's body and preferably rechargeableprovides the artificial intestine section 2 with energy. The artificialintestine section 2 is wirelessly controlled and the battery 92, ifrechargeable, wirelessly charged. A sensor 93 implanted on or within theintestine 70 delivers data on the physical conditions within theintestine 70 for controlling the artificial intestine section 2.

FIGS. 110A to 110C show a specific embodiment, wherein the artificialreservoir 40 by-passes a section of the patient's intestine 70. Thereservoir 40 has a flexible wall and a pump 41 implanted in thepatient's body separate but in close proximity to the reservoir 40 isused to empty the reservoir 40. The pump 41 is actuated by means of asubcutaneously implanted, manually operable switch 48.

FIGS. 111A and 111B show a structure similar to the one of FIGS. 110A to110C, however, with the pump 41 and the reservoir 40 being fixedlyconnected to one another. The reservoir 40 is formed by a bellow 51having an end wall 50 closing the bellow 51 at one end thereof. The endwall 50 makes part of the pump 41 such that a volume of the bellow 51can be reduced upon advancement of the end wall 50. The bellow 51 ismade of a resilient material so as to urge the bellow 51 into a normallyextended position.

FIGS. 112A and 112B show a variant to FIGS. 111A and 111B.

Here, the pump 41 and reservoir 40 are integrally combined. The pump 41is manually operable and subcutaneously mounted so as to be operablefrom the outside of the patient's body.

FIGS. 113A and 113B likewise show a variant to the system shown in FIGS.111A and 111B. While in the system of FIGS. 111A, 111B the pump 41 isautomatically driven, such as by an integrated motor, and activated viaremote control, the system in FIGS. 113A and 113B is again manuallyoperable in that the manually operable pump 41 is mountedsubcutaneously.

FIGS. 114A to 114C show a plurality of cooperating valves 61, 62, 63implanted inside the patient's body and outside the patient's intestine70. Each of the valves 61, 62, 63 comprises an electrical stimulationdevice adapted to electrically stimulate muscle or neural tissue of anintestine section so as to cause at least partial contraction of theintestine section. For that purpose, the stimulation device comprises atleast one electrode adapted to apply electric pulses to the intestinesection. While instead of the three stimulation devices shown, a singlestimulation device would be sufficient for opening and closing theintestine, the arrangement of the plurality of stimulation devices isadapted to stimulate different portions of the intestine section overtime. The function of the three stimulation devices may also be combinedin one Integral unit. The direction of natural intestinal contents flowis indicated by arrows. The different portions of the intestine sectionin a wavelike manner may be made in a direction opposite to the naturalintestinal contents flow, as shown in FIGS. 114A to 114C, so as to closethe intestine section. The stimulation in the wavelike manner may alsobe made in the direction of natural intestinal contents flow to supportemptying of the intestine or reservoir.

FIGS. 115A to 115C show the stimulation devices of FIGS. 114A to 114C incombination with constriction devices, such as the bellow valvesdescribed in relation to FIGS. 108A and 108B, for at least partlyconstricting the intestine section mechanically. Complete constrictionis obtained by additional electrical stimulation of the respectiveintestine sections. The constriction devices may be released in order toallow intestinal contents to flow through.

According to one embodiment a first and second passage is adapted toconnect to a divided intestinal portion such that intestinal mesenteryconnected thereto is opened in such a way that supply of blood throughthe mesentery to the dissected intestinal area is maintained on bothsides of the divided intestinal portion. The upstream part of theintestine with a first intestinal opening and a downstream part of theintestine with a second intestinal opening with the mesentery stillmaintaining a tissue connection between the upstream and downstreamintestine parts and the connection of the first and second passage areadapted to take such mesentery in account to allow free blood supply,when implanted.

A holding device could be adapted to hold a suture or stapler mountedthrough the peritoneal wall. The holding device could be a T-shaped or adevice having a pop-rivet design, exemplified as 150 a and 150 b of FIG.97b , where the holding device has a pop-rivet design adapted to befixated to the peritoneum or the muscular tissue of the abdomen.

The system could according to one embodiment comprise a constrictiondevice for at least partly constricting the intestine sectionmechanically or hydraulically.

The term bonded should throughout the application comprise suturing andstapling.

The mounting of the holding device to the peritoneum could prevent largemovements and movement forces acting on the connection between theintestine section and the patient's intestine against forces resultingfrom peristaltic movements and movement of the human body.

In embodiments comprising a sleeve connection, the sleeve could beadapted to increase the strength of the connection between the intestinesection and the patient's intestine against axial forces resulting fromperistaltic movements of the intestine which tend to pull on theintestine, comprising resorbable non-polymeric material.

According to one embodiment, the second open end portion could beadapted to be connected to the patient's rectum or anus or to tissueadjacent the patient's anus or to an artificial stoma, so as to form anintestine end section, so as to form an intestine end section.

The flow control device could according to one embodiment comprise atleast one valve, including an exit valve preventing intestinal contentsflow through the second open end portion in its closed position, whereinthe exit valve is a normally closed valve.

In embodiments where the system comprises a shoulder portion or holdingdevice, the shoulder portion or holding device could comprise at leastone biocompatible material selected from the following group ofmaterials: titanium, stainless steel, ceramics, biocompatible polymer,other biocompatible polymer material. The shoulder portion could beadapted to be connected to the patient's intestinal wall by sewing orstapling.

The system could comprise an artificial intestine section which couldcomprise a holding device adapted to be mounted to the peritoneum, whenimplanted, to prevent large movements and movement forces acting on theconnection between the intestine section and the patient's intestineagainst forces resulting from peristaltic movements and movement of thehuman body.

The shoulder portion of the system could be split into an upper and alower shoulder portion with a gap between the upper and lower shoulderportions adapted to accommodate intestinal wall tissue therein, whereinthe lower shoulder portion is adapted to being placed inside thepatient's intestine through a surgically created lateral opening in theintestinal wall and wherein the upper shoulder portion is adapted tobeing placed outside the intestinal wall.

Intestinal Disorder

“Artificial Intestine Section with Wirelessly Charged Accumulator”

FIG. 116a shows a system according to the present invention with anartificial intestine section being implanted inside a patient's body andhaving a first open end portion connected to a surgically createdopening in the patients intestine, more specifically to a lateralopening in a wall of the patient's intestine. The second open endportion exits the patient's abdominal wall forming a stomy. Theartificial intestine section is here shown as a black box and includesat least one energy consuming part, such as one or more valves, a pumpand/or any other flow control device, a motor for driving the same,possibly in connection with a reservoir. An accumulator is implantedalong with the artificial intestine section and can be wirelesslycharged from outside the patient's body. The energy is here galvanicallytransmitted from the accumulator to the artificial intestine section.

FIG. 116b shows a system corresponding to the one shown in FIG. 116a ,however, with the energy being transmitted wirelessly from theaccumulator to the artificial intestine section.

FIG. 116c shows a system corresponding to the one shown in FIG. 116a ,however, with the second open end portion of the artificial intestinesection exiting the patient's anus.

FIG. 117 shows a system where both the first and second open endportions of the artificial intestine section are attached to surgicallycreated lateral openings in a wall of the patient's small and/or largeintestine. The downstream part of the intestine exits the patient'sabdominal wall forming a surgically created stomy. The downstream partof the intestine may as well exit through the patients anus.

FIG. 118 shows a similar system with the difference that the second openend portion is connected to a cross-sectional opening of the patient'sintestine, further leading to the surgically created stomy. Thedownstream part of the intestine may as well exit through the patient'sanus.

FIG. 119 shows an embodiment of the artificial intestine section with anartificial reservoir and an entry valve and exit valve arranged upstreamand downstream of the reservoir. The reservoir is mounted with a pump ina common housing and the pump and the entry and exit valves arecontrolled by means of a control device, of which a part is implantedinside the patient's body. Data are transmitted wirelessly between theexternal part and implanted part of the control unit. In addition,energy is wirelessly transmitted to the artificial intestine section orto an accumulator also implanted in the patient's body and galvanicallyconnected here to the valves and pump.

FIGS. 120A and 120B show a first embodiment of the structure of FIG. 6in more detail. The pump comprises a moveable piston with a front end ofthe piston extending into the reservoir such that a volume of thereservoir is reduced upon advancement of the piston. The piston isspring loaded so as to urge the piston into a normally retractedposition. Furthermore, entry and exit valves are here realized as flapvalves. The flap valves are controlled so that one valve is open whilethe other one is closed.

FIGS. 121A and 121B show a system similar to the one of FIGS. 120A and120B. However, here the entry and exit valves comprise bellows acting onthe intestine from the outside so as to close the intestine bycompression. In FIG. 8A the bellows of the exit valve are expanded tocompress the artificial intestine section at the downstream side of thereservoir, whereas in FIG. 121B the artificial intestine section isclosed by means of the bellows of the entry valve upstream of thereservoir so that the reservoir can be emptied by advancing the pistonof the pump.

FIG. 122 shows an embodiment schematically, wherein the artificialintestine section by-passes a section of the patient's intestine, theintestine being closed by sewing so as to direct intestinal contenttowards the artificial intestine section. The enlarged area of theartificial intestine section represents any kind of element acting onthe intestinal contents within the artificial intestine section, such asa reservoir, one or more valves, a pump or any other flow controldevice, possibly including a motor, and the like. Furthermore, a batteryimplantable in the patient's body and preferably rechargeable providesthe artificial intestine section with energy. The artificial intestinesection is wirelessly controlled and the battery, if rechargeable,wirelessly charged. A sensor implanted on or within the intestinedelivers data on the physical conditions within the intestine forcontrolling the artificial intestine section.

FIGS. 123A to 123C show an embodiment, where the artificial intestinesection comprises a reservoir with a flexible wall. A pump is implantedin the patient's body separate but in close proximity to the reservoirand is used to empty the reservoir. The pump is actuated by means of asubcutaneously implanted, manually operable switch.

FIGS. 124A and 124B show a structure similar to the one of FIGS. 123A to123C, however, with the pump and the reservoir being fixedly connectedto one another. The reservoir is formed by a bellow having an end wallclosing the bellow at one end thereof. The end wall makes part of thepump such that a volume of the bellow can be reduced upon advancement ofthe end wall. The bellow is made of a resilient material so as to urgethe bellow into a normally extended position.

FIGS. 125A to 125C show a plurality of cooperating valves implantedinside the patient's body and outside the patient's intestine. These canbe positioned behind and/or in front of the artificial intestine piecealong the patient's natural intestine. Each of the valves comprises anelectrical stimulation device adapted to electrically stimulate muscleor neural tissue of an intestine section so as to cause at least partialcontraction of the intestine section. For that purpose, the stimulationdevice comprises at least one electrode adapted to apply electric pulsesto the intestine section. While instead of the three stimulation devicesshown, a single stimulation device would be sufficient for opening andclosing the intestine, the arrangement of the plurality of stimulationdevices is adapted to stimulate different portions of the intestinesection over time. The function of the three stimulation devices mayalso be combined in one integral unit. The direction of naturalintestinal contents flow is indicated by arrows. The different portionsof the intestine section in a wavelike manner may be made in a directionopposite to the natural intestinal contents flow, as shown in FIGS. 125Ato 125C, so as to close the intestine section. The stimulation in thewavelike manner may also be made in the direction of natural intestinalcontents flow to support emptying of the intestine or reservoir.

FIGS. 126A to 126C show the stimulation devices of FIGS. 125A to 125C incombination with constriction devices, such as the bellow valvesdescribed in relation to FIGS. 121A and 121B, for at least partlyconstricting the intestine section mechanically. Complete constrictionis obtained by additional electrical stimulation of the respectiveintestine sections. The constriction devices may be released in order toallow intestinal contents to flow through.

FIGS. 127A and 127B show a system comprising the artificial intestinesection connected to a cross-sectional opening of the patient'sintestine and having a valve as shown in FIG. 125 or 126 arranged aroundthe patient's intestine upstream of the artificial intestine section.Energy and/or data is transmitted wirelessly.

FIG. 128 shows the structure of an open end portion of the artificialintestine section for attaching the artificial intestine section to alateral opening in the patient's intestine by means of a shoulderportion formed around the end portion. The end portion is sewn to theintestine and may additionally or alternatively be stapled and/or gluedto the intestine.

FIG. 129 shows an improved structure for lateral attachment to theintestine, wherein the shoulder portion is split into an upper and alower shoulder portion forming a gap to accommodate intestinal walltissue therein. The surface area of the upper shoulder portion is largerthan the surface area of the lower shoulder portion.

FIG. 130 shows an enlarged view of a ring-and-bulge connection by whichthe artificial intestine section and the patient's downstream intestinalpart are connected, as shown in FIG. 118.

FIGS. 131A and 131B show the ring-and-bulge connection of FIG. 130 incombination with a sleeve. The sleeve is rolled upon itself and can beunrolled such that a part of the intestine is located intermediate thesleeve and the conduit. Thereafter, the ring is pushed over the sleeveagainst the bulge.

FIGS. 132A and 132B show a connection of the artificial intestinesection to a cross-sectional opening of the patient's intestine similarto the connection shown in FIGS. 131A and 131B, however, without thebulge and the ring.

FIGS. 133A and 133B show an alternative to the connection in FIGS. 19Aand 19B. Instead of unrolling the sleeve, it is simply pulled over theintestine.

FIGS. 134A and 134B show another sleeve connection. Here, the sleeve ismounted on the outer surface of the open end portion so as to befoldable upon itself. By folding the flexible sleeve upon itself, a partof the intestine is located intermediate the folded sleeve.

According to one embodiment a first and second passage is adapted toconnect to a divided intestinal portion such that intestinal mesenteryconnected thereto is opened in such a way that supply of blood throughthe mesentery to the dissected intestinal area is maintained on bothsides of the divided intestinal portion. The upstream part of theintestine with a first intestinal opening and a downstream part of theintestine with a second intestinal opening with the mesentery stillmaintaining a tissue connection between the upstream and downstreamintestine parts and the connection of the first and second passage areadapted to take such mesentery in account to allow free blood supply,when implanted.

A holding device could be adapted to hold a suture or stapler mountedthrough the peritoneal wall. The holding device could be a T-shaped or adevice having a pop-rivet design, exemplified as 150 a and 150 b of FIG.97b , where the holding device has a pop-rivet design adapted to befixated to the peritoneum or the muscular tissue of the abdomen.

The system could according to one embodiment comprise a constrictiondevice for at least partly constricting the intestine sectionmechanically or hydraulically.

The term bonded should throughout the application comprise suturing andstapling.

The mounting of the holding device to the peritoneum could prevent largemovements and movement forces acting on the connection between theintestine section and the patient's intestine against forces resultingfrom peristaltic movements and movement of the human body.

In embodiments comprising a sleeve connection, the sleeve could beadapted to increase the strength of the connection between the intestinesection and the patient's intestine against axial forces resulting fromperistaltic movements of the intestine which tend to pull on theintestine, comprising resorbable non-polymeric material.

According to one embodiment, the second open end portion could beadapted to be connected to the patient's rectum or anus or to tissueadjacent the patients anus or to an artificial stoma, so as to form anintestine end section, so as to form an intestine end section.

The flow control device could according to one embodiment comprise atleast one valve, including an exit valve preventing intestinal contentsflow through the second open end portion in its closed position, whereinthe exit valve is a normally closed valve.

In embodiments where the system comprises a shoulder portion or holdingdevice, the shoulder portion or holding device could comprise at leastone biocompatible material selected from the following group ofmaterials: titanium, stainless steel, ceramics, biocompatible polymer,other biocompatible polymer material. The shoulder portion could beadapted to be connected to the patient's intestinal wall by sewing orstapling.

The system could comprise an artificial intestine section which couldcomprise a holding device adapted to be mounted to the peritoneum, whenimplanted, to prevent large movements and movement forces acting on theconnection between the intestine section and the patient's intestineagainst forces resulting from peristaltic movements and movement of thehuman body.

The shoulder portion of the system could be split into an upper and alower shoulder portion with a gap between the upper and lower shoulderportions adapted to accommodate intestinal wall tissue therein, whereinthe lower shoulder portion is adapted to being placed inside thepatient's intestine through a surgically created lateral opening in theintestinal wall and wherein the upper shoulder portion is adapted tobeing placed outside the intestinal wall.

Intestinal Disorder

“Artificial Intestine Section” Intestine-By-Pass Flow Control

FIG. 135 shows a system according to the present invention with anartificial intestine section being implanted inside a patient's body andhaving a first open end portion connected to a surgically createdlateral opening in a wall of the patient's intestine. The second openend portion exits the patient's abdominal wall forming a stomy. Theartificial intestine section is here shown as a black box and mayinclude an artificial reservoir for intestinal contents, a motor, one ormore valves, a pump and/or any other flow control device.

The system shown in FIG. 136 corresponds to the one shown in FIG. 1,however, with the second open end portion of the artificial intestinesection exiting the patient's anus.

FIG. 137 shows a system where both the first and second open endportions of the artificial intestine section are attached to surgicallycreated lateral openings in a wall of the patient's small and/or largeintestine. The downstream part of the intestine exits the patientsabdominal wall forming a surgically created stomy. The downstream partof the intestine may as well exit through the patients anus.

FIG. 138 shows a similar system with the difference that the second openend portion is connected to a cross-sectional opening of the patient'sintestine, further leading to the surgically created stomy. Thedownstream part of the intestine may as well exit through the patient'sanus.

FIG. 139 shows the structure of the first open end portion of theartificial intestine section for attaching the artificial intestinesection to the lateral opening in the patient's intestine by means of ashoulder portion formed around the end portion. The end portion is sewnto the intestine and may additionally or alternatively be stapled and/orglued to the intestine.

FIG. 140 shows an improved structure for lateral attachment to theintestine, wherein the shoulder portion is split into an upper and alower shoulder portion forming a gap to accommodate intestinal walltissue therein. The surface area of the upper shoulder portion is largerthan the surface area of the lower shoulder portion.

FIG. 141 shows an enlarged view of a ring-and-bulge connection by whichthe artificial intestine section and the patient's downstream intestinalpart are connected, as shown in FIG. 138.

FIGS. 142A and 142B show the ring-and-bulge connection of FIG. 141 incombination with a sleeve. The sleeve is rolled upon itself and can beunrolled such that a part of the intestine is located intermediate thesleeve and the conduit. Thereafter, the ring is pushed over the sleeveagainst the bulge.

FIGS. 143A and 143B show a connection of the artificial intestinesection to the cross-sectional opening of the patient's intestinesimilar to the connection shown in FIGS. 142A and 142B, however, withoutthe bulge and the ring.

FIGS. 144A and 144B show an alternative to the connection in FIGS. 9Aand 9B. Instead of unrolling the sleeve, it is simply pulled over theintestine.

FIGS. 145A and 145B show another sleeve connection. Here, the sleeve ismounted on the outer surface of the open end portion so as to befoldable upon itself. By folding the flexible sleeve upon itself, a partof the intestine is located intermediate the folded sleeve.

FIG. 146 shows an embodiment of the artificial intestine section with anartificial reservoir and an entry valve and exit valve arranged upstreamand downstream of the reservoir. The reservoir is mounted with a pump ina common housing and the pump and the entry and exit valves arecontrolled by means of a control device, of which a part is implantedinside the patient's body. Data are transmitted wirelessly between theexternal part and implanted part of the control unit. In addition,energy is wirelessly transmitted to the artificial intestine section orto an accumulator also implanted in the patient's body and galvanicallyconnected here to the valves and pump.

FIGS. 147A and 147B show a first embodiment of the structure of FIG. 146in more detail. The pump comprises a moveable piston with a front end ofthe piston extending into the reservoir such that a volume of thereservoir is reduced upon advancement of the piston. The piston isspring loaded so as to urge the piston into a normally retractedposition. Furthermore, entry and exit valves are here realized as flapvalves. The flap valves are controlled so that one valve is open whilethe other one is closed.

FIGS. 148A and 148B show a system similar to the one of FIGS. 147A and147B. However, here the entry and exit valves comprise bellows acting onthe intestine from the outside so as to close the intestine bycompression. In FIG. 148A the bellows of the exit valve are expanded tocompress the artificial intestine section at the downstream side of thereservoir, whereas in FIG. 148B the artificial intestine section isclosed by means of the bellows of the entry valve upstream of thereservoir so that the reservoir can be emptied by advancing the pistonof the pump.

FIG. 149 shows an embodiment schematically, wherein the artificialintestine section by-passes a section of the patient's intestine, theintestine being closed by sewing so as to direct intestinal contenttowards the artificial intestine section. An exit valve is provided forcontrolling the flow of intestinal contents from the artificialintestine section. The enlarged area of the artificial intestine sectionrepresents any kind of element acting on the intestinal contents withinthe artificial intestine section, such as a reservoir, one or morevalves, a pump or any other flow control device, possibly including amotor, and the like.

FIG. 150 shows a by-passing artificial intestine section in action,further leading to a surgically created stoma. A pump or valve may becontained in the artificial intestine section.

FIG. 151 shows the artificial intestine section of FIG. 150 with a largereservoir and an exit valve downstream the reservoir.

FIG. 152 shows the by-passing artificial intestine section including apump and a valve incorporated therein. Furthermore, a batteryimplantable in the patient's body and preferably rechargeable providesthe artificial intestine section with energy. The artificial intestinesection is wirelessly controlled and the battery, if rechargeable,wirelessly charged. A sensor implanted on or within the Intestinedelivers data on the physical conditions within the intestine forcontrolling the artificial intestine section.

FIGS. 153A to 153C show an embodiment, where the artificial intestinesection comprises a reservoir with a flexible wall. A pump is implantedin the patient's body separate but in close proximity to the reservoirand is used to empty the reservoir. The pump is actuated by means of asubcutaneously implanted, manually operable switch.

FIGS. 153D and 153E show a structure similar to the one of FIGS. 153A to153C, however, with the pump and the reservoir being fixedly connectedto one another. The reservoir is formed by a bellow having an end wallclosing the bellow at one end thereof. The end wall makes part of thepump such that a volume of the bellow can be reduced upon advancement ofthe end wall. The bellow is made of a resilient material so as to urgethe bellow into a normally extended position.

FIGS. 154A and 154B show a variant to FIGS. 153A and 153B.

Here, the pump and reservoir are integrally combined. The pump ismanually operable and subcutaneously mounted so as to be operable fromthe outside of the patient's body.

FIGS. 155A and 155B likewise show a variant to the system shown in FIGS.153A and 153B. While in the system of FIGS. 153D, 153E the pump isautomatically driven, such as by an integrated motor, and activated viaremote control, the system in FIGS. 155A and 155B is again manuallyoperable in that the manually operable pump is mounted subcutaneously.

FIGS. 160A to 160C show a plurality of cooperating valves implantedinside the patient's body and outside the patient's intestine. These canbe positioned behind and/or in front of the artificial intestine piecealong the patient's natural intestine. Each of the valves comprises anelectrical stimulation device adapted to electrically stimulate muscleor neural tissue of an intestine section so as to cause at least partialcontraction of the intestine section. For that purpose, the stimulationdevice comprises at least one electrode adapted to apply electric pulsesto the intestine section. While instead of the three stimulation devicesshown, a single stimulation device would be sufficient for opening andclosing the intestine, the arrangement of the plurality of stimulationdevices is adapted to stimulate different portions of the intestinesection over time. The function of the three stimulation devices mayalso be combined in one integral unit. The direction of naturalintestinal contents flow is indicated by arrows. The different portionsof the intestine section in a wavelike manner may be made in a directionopposite to the natural intestinal contents flow, as shown in FIGS. 160Ato 160C, so as to close the intestine section. The stimulation in thewavelike manner may also be made in the direction of natural intestinalcontents flow to support emptying of the intestine or reservoir.

FIGS. 161A to 161C show the stimulation devices of FIGS. 160A to 160C incombination with constriction devices, such as the bellow valvesdescribed in relation to FIGS. 161A and 161B, for at least partlyconstricting the intestine section mechanically. Complete constrictionis obtained by additional electrical stimulation of the respectiveintestine sections. The constriction devices may be released in order toallow intestinal contents to flow through.

FIG. 162 shows a system similar to the system of FIG. 135, however, witha flow control device in the form of an exit valve being implantedwithin the artificial intestine section. An external manually drivensuction pump is used for emptying the artificial intestine section,wherein a conduit on the front end of the pump is inserted from outsidethe patient's body into the intestine, thereby mechanically urging theexit valve to open.

The system could include a first intestinal passage way in flowcommunication with the reservoir arranged for transferring intestinalcontents to the reservoir, and a second intestinal passage way in flowcommunication with the reservoir, said second passage way being arrangedfor transferring intestinal contents from the reservoir.

The system may further comprise a pump for emptying said reservoir,wherein the second passage way is adapted to being surgically connectedto a surgically created stoma and wherein said pump is adapted to pumpintestinal contents out through said stoma or being surgically connectedto the patient's anus or to tissue adjacent the patient's anus andwherein said pump is adapted to pump intestinal contents out through thepatient's anus or to tissue adjacent the patient's anus.

The pump may be adapted to pump intestinal contents into to the smallintestine and out from said reservoir or to pump into the largeintestine and out from said reservoir.

The second passage way may include the large intestine or largeintestine or an artificial intestinal piece.

The reservoir has an upstream part of the reservoir with a first openend and a downstream part of the reservoir with a second open end,wherein the downstream part is adapted to be advanced through theabdominal wall and skin and, thereby achieving an intestinal stomy or,wherein the downstream intestinal part is adapted to be connected to thepatient's anus or tissue adjacent the patient's anus or, wherein thesecond open end is adapted to being connected to an artificialintestinal piece.

The artificial intestinal piece may comprise a valve for controlling theflow of intestinal contents and adapted to be connected to the patient'ssmall intestine or large intestine.

The system may comprise a holding device adapted to be mounted to theperitoneum, when implanted, to prevent large movements and movementforces acting on the connection between the intestine section and thepatient's intestine against forces resulting from peristaltic movementsand movement of the human body.

The holding device may be adapted to hold a suture or stapler mountedthrough the peritoneal wall or comprise a part intended for placementoutside the peritoneum, when implanted, adapted to pass through theperitoneal wall and hold said intestinal section.

The holding device may also comprise a flange intended for placementoutside the peritoneum, when implanted, to hold said artificialintestine section.

According to one embodiment, the artificial intestine section has boththe first and second open end portions adapted to be connected to asurgically created lateral opening in a wall of the patient's intestineor wherein the first and second open end portions are connecteddifferently, one to a surgically created lateral opening of theintestine and one to a surgically created divided cross-sectionalopening.

According to another embodiment the artificial intestine sectioncomprises a holding device adapted to be mounted to the peritoneum, whenimplanted, to prevent large movements and movement forces acting on theconnection between the intestine section and the patient's intestineagainst forces resulting from peristaltic movements and movement of thehuman body.

According to one embodiment the artificial reservoir is a reservoir forreceiving and temporarily collecting intestinal contents suppliedthrough the first open end portion, is adapted to be emptied to moveintestinal contents out through the second open end portion.

According to one embodiment the system comprises an extra valvecomprising at least one of; at least one electrical stimulation deviceadapted to electrically stimulate muscle or neural tissue of the naturalintestine section so as to cause at least partial contraction of thenatural intestine section and one hydraulic or mechanic constrictiondevice to restrict the natural intestine section.

According to one embodiment the system comprises a flow control devicecomprising at least one valve, wherein the at least one motor isarranged for driving at least one of the valve or valves, respectively,between closed and open positions.

According to one embodiment the system comprises a pump for movingintestinal contents in the artificial section, wherein the at least onemotor is arranged for driving the pump.

According to one embodiment the system comprises a manually operableswitch for activating the at least one motor, the switch being arrangedfor subcutaneous implantation so as to be operable from outside thepatient's body.

According to one embodiment the system comprises a holding deviceadapted to pass through the peritoneal wall and hold said intestinalsection, comprising a flange intended for placement outside theperitoneum or the holding device being adapted to hold sutures andstaplers passing through the peritoneal wall, when implanted, to holdsaid artificial intestine section.

According to one embodiment the system comprises an energy sourcecomprising an implantable accumulator, wherein the accumulator comprisesone or more of a rechargeable battery and a capacitor.

According to one embodiment the system comprises the energy sourcecomprises a wireless energy transmitter adapted to wirelessly transmitenergy from outside the patient's body to the at least one energyconsuming part, wherein the system further comprising a feedbacksubsystem adapted to wirelessly send feedback information related to theenergy to be stored in the accumulator from inside the human body to theoutside thereof, wherein the system is adapted to use the feedbackinformation for adjusting the amount of wireless energy transmitted bythe energy transmitter.

Intestinal Disorder

“Intestinal Pump”

FIG. 163A schematically shows a general embodiment of the apparatusaccording to the present invention for treating a patient suffering froma disorder related to the passageway of the patient's intestines, suchas constipation or anal incontinence. The apparatus includes a pump 1externally applied on a selected portion 2 of the patient's intestines3, such as a portion of the large intestine. The pump 1 includes aconstriction device for constricting the selected portion 2 to displaceintestinal contents therein. In operation, the apparatus cyclicallychanges between a first stage of operation, in which the constrictiondevice does not constrict the selected portion 2 to allow intestinalcontents to fill the selected portion 2, as illustrated in FIG. 163A,and a second stage of operation, in which the constriction deviceconstricts the selected portion 2 to at least substantially reduce thevolume of the passageway of the intestines 4 along the selected portion2, so that the selected portion 2 of the tubular intestine 3 is at leastpartially flattened. As a result, intestinal contents is displaced outof the selected portion 2 downstream in the intestine 3 and dischargesthrough an open end 5 of the intestine 3, as illustrated in FIG. 163B.When the apparatus changes from the second stage of operation (FIG.163B) to the first stage of operation (FIG. 163A), the constrictiondevice of the pump 1 releases the selected portion 2 to allow intestinalcontents to enter the selected portion 2, whereby the volume of thepassageway of the intestines 4 along the selected portion 2 is increasedas intestinal contents fills the selected portion 2.

The apparatus of FIG. 163A may be provided with an electric stimulationdevice for electrically stimulating muscle or neural tissue of theselected portion 2 to cause contraction of the intestinal wall 6, sothat the intestinal wall 6 thickens. When operating the apparatusprovided with such a stimulation device, the apparatus cyclicallyperforms a sequence of three stages of operation, namely a first stageof operation, in which the constriction device of the pump 1 does notconstrict the selected portion 2 to allow intestinal contents to fillthe selected portion 2, as illustrated in FIG. 163A, a second stage ofoperation, in which the constriction device constricts the selectedportion 2 so that the latter is partially flattened, as illustrated inFIG. 164A, whereby some intestinal contents is displaced downstream inthe intestine 3 and discharges through the open end 5, and a third stageof operation, in which the electric stimulation device stimulates theconstricted selected portion 2 with electric pulses (indicated by arrowsA in FIG. 164B) to thicken the intestinal wall 6 to completely close thepassageway of the intestines 4, whereby more intestinal contents isdisplaced downstream in the intestine 3 and discharges through the openend 5, see FIG. 164B. The use of the electric stimulation device foraccomplishing complete closing of the passageway of the intestines 4enables the constriction device of the pump 1 to partially constrict theselected portion 2 without substantially hampering the blood circulationin the intestinal tissue.

FIGS. 165A, 165B and 165C schematically illustrate an embodiment of theinvention, which is similar to the general embodiment according to FIGS.163A and 163B, except that the apparatus includes a peristaltic type ofpump 7. The peristaltic pump 7 includes a constriction device thatprovides a limited constriction 8 of the selected portion 2 extendingalong a part of the selected portion 2, see FIG. 165A. A control device9 is provided for controlling the constriction device of the peristalticpump 7 to displace the constriction 8 in the downstream direction (fromleft to right in FIGS. 165A-165C) to move intestinal contents forwardsin the passageway of the intestines 4, as illustrated in FIGS. 165Athrough 165C. When the constriction 8 has been displaced to the rightend of the selected portion 2 and intestinal contents has entered andrefilled the selected portion 2 upstream of the constriction 8, thecontrol device 9 controls the constriction device of the peristalticpump 7 to release the selected portion 2 at its right end and to applythe constriction 8 at the left end of the selected portion 2, asillustrated in FIG. 165A, whereby the above described operation can berepeated.

FIGS. 166A, 166B and 166C schematically illustrate an embodiment of theinvention, which is similar to the embodiment according to FIGS. 165A,165B and 165C, except that the apparatus of the embodiment of FIGS.165A-165C also includes an electric stimulation device having the samepurpose as the electric stimulation device described above in connectionwith the embodiment according to FIGS. 164A and 164B. In the embodimentof FIGS. 166A-166C, a limited constriction 10 of the selected portion 2is provided by the combination of two measures. Thus, in accordance witha first measure, the constriction device of the peristaltic pump 7constricts a part of the selected portion 2 so that the latter partiallyflattens but does not close the passageway of the intestines 4. Inaccordance with a following second measure, the electric stimulationdevice stimulates the constricted part of the selected portion 2 withelectric pulses (indicated by arrows B in FIGS. 165A-165C) to thickenthe intestinal wall to completely close the passageway of theintestines, whereby the constriction 10 is created. The control device 9controls the constriction device and stimulation device to displace theconstriction 10 in the same manner as described above for thecorresponding constriction 8 according to the embodiment of FIGS.165A-165C.

FIGS. 167A, 167B and 167C show an embodiment of the invention, in whichthe apparatus includes a pump 11 having a constriction device 12designed to constrict, i.e., flatten a selected portion 2 of thepatient's intestines 3. Thus, the constriction device 12 includes anupstream first pair of short constriction elements 13A and 13B, adownstream second pair of short constriction elements 14A and 14B, and athird pair of elongate constriction elements 15A and 15B positionedbetween the first and second short element pairs. The two shortconstriction elements 13A,13B of the first pair are radially movabletowards and away from each other between retracted positions (FIG. 167A)and constricting positions (FIGS. 167B and 167C), the two shortconstriction elements 14A, 14B of the second pair are radially movabletowards and away from each other between retracted positions (FIG. 167C)and constricting positions (FIGS. 167A and 167B), and the two elongateconstriction elements 167A, 167B of the third pair are radially movabletowards and away from each other between retracted positions (FIGS. 167Aand 167B) and constricting positions (FIG. 167C). The pump 11 is appliedon to the selected portion 2 so that the two constriction elements ofeach pair of constriction elements are positioned at opposite sides ofthe selected portion 2, the short constriction elements 13A, 13B beingpositioned at an upstream end of the selected portion 2, and the shortconstriction elements 14A, 14B being positioned at a downstream end ofthe selected portion 2.

The control device 9 controls the pair of short constriction elements13A, 13B, the pair of elongate constriction elements 15A, 15B and thepair of short elements 14A, 14B to constrict and release the selectedportion 2 independently of one another. FIGS. 167A-167C illustrate howthe control device 9 controls the operation of the pump 11 to cyclicallydisplace intestinal contents in the downstream direction of thepassageway of the intestines 4. Thus, in FIG. 167A the shortconstriction elements 13A, 13B and the elongate constriction elements15A, 15B are in their retracted positions, whereas the shortconstriction elements 14A, 14B are in their constricting positions. FIG.167B illustrates how the short constriction elements 13A, 13B have alsobeen moved radially inwardly to their constricting positions, whereby avolume of intestinal contents is trapped in the passageway of theintestines 4 between the upstream and downstream ends of the selectedportion 2. FIG. 167C illustrates how the short constriction elements14A, 14B initially have been moved radially outwardly to their retractedpositions, and then the elongate constriction elements 15A, 15B havebeen moved radially inwardly to their constricting positions. As aresult, the intestinal contents in the passageway of the intestines 4between the upstream and downstream ends of the selected portion 2 hasbeen moved downstream in the passageway of the intestines 4, asindicated by an arrow. Then, the control device 9 controls theconstriction device 12 to assume the state shown in FIG. 167A to allowintestinal contents to enter and fill the passageway of the intestinesbetween the upstream and downstream ends of the selected portion 2,whereby the pumping cycle is completed.

Although FIGS. 167A-167C disclose pairs of constriction elements, itshould be noted that it is conceivable to design the constriction device12 with only a single short constriction element 13A, a single elongateconstriction element 15A and a single short constriction element 14A. Insuch a case, the selected portion 2 of the intestine 3 is supported bystationary elements of the constriction device 12 positioned at the sideof the selected portion 2 which is opposite to the constriction elements13A, 14A and 15A.

FIGS. 168A, 168B and 168C show an embodiment of the invention, which issimilar to the embodiment according to FIGS. 167A, 167B and 167C, exceptthat the apparatus according to FIGS. 168A-168C also includes anelectric stimulation device having the same purpose as the electricstimulation device described above in connection with the embodimentaccording to FIGS. 164A and 164B. The stimulation device according toFIGS. 168A-168C includes rows of electrodes 16 positioned on theconstriction elements 13A, 13B, 14A, 14B, 15A and 15B and adapted tostimulate muscle or neural tissue of the selected portion of theintestinal tissue with electric pulses. In FIGS. 168A-168C, inactivatedelectrodes 16 are indicated by unfilled rings, whereas activatedelectrodes 16 are indicated by black round spots. In this embodiment,the constriction device and stimulation device cooperate to avoidhampering the blood circulation in the intestinal tissue. Thus, the twoconstriction elements of each pair of constriction elements are adaptedto constrict the selected portion no more than to almost close thepassageway of the intestines. The final complete closure of thepassageway of the intestines is achieved by the electrodes 16stimulating the constricted selected portion 2 with electric pulses, sothat the intestinal wall thickens and completely closes the passagewayof the intestines.

In operation of the apparatus according to FIGS. 168A-168C, the controldevice 9 controls the constriction elements 13A-15B to move in the samesequence as described above in connection with the embodiment accordingto FIGS. 167A-167C. The control device 9 also controls the electrodes 16to electrically stimulate the intestinal tissue where any one of theconstriction elements 13A-15A constricts the selected portion 2.

FIG. 169 shows the same embodiment as that of FIG. 168C illustrating amodified operation of the electrodes 16 on the elongate constrictionelements 15A and 15B. Thus, the control device 9 controls the electrodes16 to successively stimulate the selected portion 2 where the elongateconstriction elements 15A, 15B constrict the selected portion 2, so thatthe constricted selected portion is progressively contracted in thedownstream direction. As a result, intestinal contents is displaceddownstream in the passageway of the intestines in a peristaltic manner.Alternatively, the electrodes 16 may successively stimulate the selectedportion 2 to progressively contract the portion 2 in the upstreamdirection.

FIG. 170 shows the embodiment of FIG. 168A when the pump 11 is not inoperation and the constriction elements 13A-15B are maintained in a restposition. Thus, the short upstream and downstream constriction elements13A, 13B, 14A and 14B are kept in their retracted positions, whereas theelongate constriction elements 15A,15B gently constrict the selectedportion to at least substantially decrease the cross-sectional area ofthe passageway of the intestines. The control device 9 controls all ofthe electrodes 16 on the constriction elements 15A, 15B to electricallystimulate the constricted selected portion 2 to thicken the intestinalwall so that the passageway of the intestines is kept completely closed.Alternatively, only a part of the constricted portion may be stimulatedat a time.

FIGS. 171A, 171B, 171C and 171D illustrate a modified operation of theelectrodes 16 of the embodiment according to FIG. 168A when the pump 11is not in operation. Referring to FIG. 171A, there are eight electrodespositioned in a row along constriction element 15A and eight electrodespositioned in a row along constriction element 15B. The control device 9activates the electrodes in the two rows of electrodes in accordancewith a preset scheme to cause partial contractions of the selectedportion 2 that over time change their positions on the selected portion,whereby parts of the intestines that currently are not stimulated canrestore substantially normal blood circulation before they arestimulated again. Starting from the electrodes positioned in the middleof the elongate constriction elements 15A, 15B, the electrodes areprogressively activated in the direction upstream and the directiondownstream of the intestines.

Thus, the control device 9 activates two pairs of adjacent electrodes16A and 16B positioned centrally in the two rows of electrodes tothicken the intestinal wall along a short distance of the selectedportion 2 to close the passageway of the intestines in the middle of theselected portion 2. Referring to FIG. 171B, after the laps of apredetermined time period, in the order of seconds, a next pair ofelectrodes 16C to the left of the electrode pair 16A and a next pair ofelectrodes 16D to the right of the electrode pair 16B are activated,whereas the electrodes 16A and 16B are inactivated. As a result, theintestinal wall is thickened at two different positions spaced from themiddle of the selected portion 2. Referring to FIG. 9C, after the lapsof another predetermined time period, a next pair of electrodes 16E tothe left of the electrode pair 16C and a next pair of electrodes 16F tothe right of the electrode pair 16D are activated, whereas theelectrodes 16C and 16D are inactivated. As a result, the intestinal wallis thickened at two positions spaced farther from the middle of theselected portion 2. Referring to FIG. 171D, after the laps of yetanother predetermined time period, a next pair of electrodes 16G to theleft of the electrode pair 16E and a next pair of electrodes 16H to theright of the electrode pair 16F are activated, whereas the electrodes16E and 16F are inactivated. Then, the above described stimulationoperation according to FIGS. 171A-171D is cyclically repeated until thepump 11 is to be operated.

FIGS. 172A, 172B and 172C show an embodiment of the invention, which issimilar to the embodiment according to FIGS. 168A, 168B and 168C, exceptthat the movable elongate constriction elements 15A and 15B are replacedby two elongate stationary elements 17A and 17B. The stimulation deviceof this embodiment includes rows of electrodes 16 positioned on thestationary elements 17A, 178 and adapted to electrically stimulate theintestinal wall of the selected portion 2 to reduce the volume of thepassageway of the intestines 4 between the upstream and downstream endsof the selected portion 2. Thus, FIG. 172C illustrates how the shortconstriction elements 14A, 14B initially have been moved radiallyoutwardly to their retracted positions, and then the electrodes 16 havebeen activated to cause contraction of the intestinal wall so that thevolume of the passageway of the intestines between the upstream anddownstream ends of the selected portion 2 is reduced, whereby intestinalcontents is moved downstream in the passageway of the intestines 4 asindicated by an arrow. For the sake of clarity, the thickness of theintestinal wall subjected to electric stimulation by the electrodes 16is exaggerated in FIG. 172C.

FIGS. 173A and 173B are views of another embodiment of the inventionshowing different stages of operation, wherein a rotary peristaltic pump18 is applied on the small intestines 19 of a colostomy patient near thestoma. The peristaltic pump 18 includes a rotor 20 carrying aconstriction device 21 in the form of three cylindrical constrictionelements 22A, 22B and 22C positioned equidistantly from the axis 23 ofthe rotor 20. The constriction elements 22A-22C may be designed asrollers. A stationary elongate support element 24 is positioned spacedfrom but close to the rotor 20 and has a part cylindrical surface 25concentric with the axis 23 of the rotor 20. The pump 18 is applied onthe small intestines 19, so that the intestine 19 extends between thesupport element 24 and the rotor 20.

The control device 9 controls the rotor 20 to rotate so that theconstriction elements 22A-22C successively constrict portions of aseries of selected portions of the intestines 19 against the elongatesupport element 24. FIG. 173A illustrates how the constriction element22A constricts intestines 19 at a first portion 25 and closes thepassageway of intestines 4, whereas the constriction element 22B isabout to release intestine 19 at a second portion 26 downstream of thefirst portion 25. FIG. 173B illustrates how the constriction element 22Ahas advanced about halfway along the elongate support element 24 anddisplaced the intestinal contents in the passageway of the intestines sothat some intestinal contents discarges through the stoma. Theconstriction element 22B has released intestines 19, whereas theconstriction element 22C is about to engage intestines 19. Thus, thecontrol device 9 controls the rotor 20 to cyclically move theconstriction elements 22A-22C one after the other along the elongatesupport element 24 while constricting the selected portions ofintestines 19, so that intestinal contents in the passageway ofintestines 4 is displaced in a peristaltic manner. The same constrictionprinciple may also be practised by other mechanical constriction devicesthat do not include a rotor.

FIGS. 174A and 174B show an embodiment of the invention, which issimilar to the embodiment according to FIGS. 173A and 173B, except thatthe apparatus of the embodiment of FIGS. 174A-174B also includes anelectric stimulation device having the same purpose as the electricstimulation device described above in connection with the embodimentaccording to FIGS. 166A-166C. The stimulation device according to FIGS.174A-174B includes electrodes 16 provided on the constriction elements22A-22C. In this embodiment, the rotor 20 is spaced somewhat fartherfrom the stationary elongate support element 23, as compared with theembodiment according to FIGS. 173A and 173B, so that the constrictionelements 22A-22C do not completely close the passageway of theintestines by mechanical action, as they constrict intestine 19 duringrotation of the rotor 20. Complete closure of the passageway ofintestines 4 is accomplished by activation of the electrodes 16. Thesame combined constriction and stimulation principle may also bepractised by other mechanical constriction devices that do not include arotor.

Thus, when any one of the constriction elements 22A-22C constricts aportion of intestines 19, its associated electrodes 16 electricallystimulate the constricted portion with electric pulses so that theintestinal wall of the constricted portion thickens and closes thepassageway of intestines 4.

FIGS. 175A through 175D are longitudinal cross-sections of anotherembodiment of the invention showing different stages of operation,wherein another type of peristaltic pump 27 is applied on a selectedportion of the patient's intestines 19. The pump 27 comprises aconstriction device 28 including two elongate constriction elements 29Aand 29B having convex surfaces 30A and 30B that abut a length of theselected portion on mutual sides thereof. The control device 9 controlsthe elongate constriction elements 29A, 29B to move relative to theselected portion so that the constriction elements 29A, 29Bprogressively constrict the selected portion, as shown in FIGS. 175A to175D.

Thus, in an initial position of the constriction elements 29A, 29B shownin FIG. 175A, the selected portion is not constricted by theconstriction elements 29A, 29B. Starting from this initial position, thecontrol device 9 controls the constriction elements 29A, 29B to swingthe left ends of the constriction elements 29A, 29B toward the selectedportion (indicated by arrows) to constrict the selected portion ofintestines 19, see FIG. 175A. FIG. 175B shows how the passageway ofintestines 4 is completely closed by the constricted selected portion.Then, as shown in FIG. 175B, the control device 9 controls theconstriction elements 29A, 29B to move so that their right ends movetowards each other (indicated by arrows), while the convex surfaces 30A,30B of the constriction elements 29A, 29B are rolling on each other withthe constricted selected portion between them, see FIG. 175C. As aresult, intestinal contents in intestines 19 is forced to the right(indicated by a white arrow). When the constriction elements 29A, 29Bhave rolled on each other to the position shown in FIG. 175D, thecontrol device 9 controls the constriction elements 29A, 29B to movetheir right ends away from each other (indicated by arrows in FIG. 175D)to the initial position shown in FIG. 175A. The operation stages shownin FIGS. 175A to 175D can be cyclically repeated a number of times untilthe desired amount of intestinal contents has been displaced in thepassageway of the intestines in a peristaltic manner. This embodiment isparticularly suited for use in a stoma patient. Thus, the peristalticpump 27 is applied on the patient's intestines close to the patient'sstoma.

Alternatively, only one of the constriction elements 29A, 29B can beprovided with a convex surface, whereas the other constriction elementhas a plane surface that abuts the selected portion. It is also possibleto use a single constriction element with a convex surface that pressesthe selected portion of the intestine 19 against a bone of the patient.

FIGS. 176A through 176D show an embodiment of the invention, which issimilar to the embodiment according to FIGS. 175A-175D, except that theapparatus of the embodiment of FIGS. 176A-176D also includes an electricstimulation device having the same purpose as the electric stimulationdevice described above in connection with the embodiment according toFIGS. 166A-166C. The stimulation device includes electrodes 16positioned on the convex surfaces 30A, 30B. In the embodiment of FIGS.176A-176D, the constriction elements 29A and 29B are spaced somewhatfarther from each other, as compared with the embodiment according toFIGS. 175A-175D, so that the constriction elements 29A, 29B do notcompletely close the passageway of the intestines 4 by mechanicalaction, as they constrict the intestine 19 during operation. Completeclosure of the passageway of the intestines 4 is accomplished byactivation of the electrodes 16.

Thus, with the constriction elements 29A. 29B in the initial positionshown in FIG. 176A, the control device 9 controls the constrictionelements 29A, 29B to swing the left ends thereof toward the selectedportion of the intestines 19 (indicated by arrows) to constrict theselected portion, while controlling the electrodes 16 to electricallystimulate the intestine 19 to cause contraction and thickening of theintestinal wall. FIG. 176B shows how the passageway of the intestines 4is completely closed by the combination of the mechanical constrictionof the intestine 19 by the constriction elements 29A, 29 B and theelectric stimulation of the intestine 19 by the electrodes 16. FIGS.176C and 176D shows operation stages that correspond to the operationstages of FIGS. 175C and 175D described above.

In the embodiment according to FIGS. 176A to 176D, the control device 9may control the electrodes 16 to progressively stimulate the constrictedselected portion to cause progressive contraction thereof in harmonywith the movement of the elongate constriction elements 29A 29B, as theconvex surfaces 30A, 30B of the constriction elements 29A, 29B arerolling on each other.

FIGS. 177A and 177B show different stages of operation of anotherembodiment of the invention, in which the apparatus includes a separatepump 31 and a separate releasable closure 32 applied on a selectedportion of a patient's intestine 19. The pump 31 is of the typedescribed above, which includes a constriction device that alternatelyconstricts and releases the selected portion of the intestines 19, suchthat intestinal contents is displaced through the passageway of theintestines 4. The closure 32 includes two elongate constriction elements33A and 33B, which are positioned at opposite sides of the selectedportion. The constriction elements 33A, 33B are radially movable towardsand away from each other between retracted positions (FIG. 177A), inwhich the selected portion of the intestine 19 is released when the pump31 is in operation, and constricting positions, in which theconstriction elements 33A, 33B constrict the selected portion to closethe passageway of the intestines when the pump is not in operation.

There is a stimulation device including rows of electrodes 16 positionedon the constriction elements 33A, 33B for stimulating muscle or neuraltissue of the selected portion of the intestine 19 with electric pulsesto cause contraction of the intestinal wall. FIG. 177A illustrates theelectrodes 16 by unfilled rings indicating inactivated electrodes andFIG. 177B illustrates the electrodes 16 by black round spots indicatingactivated electrodes. The constriction elements 33A, 33B and electrodes16 cooperate to avoid hampering the blood circulation in the intestinaltissue, when the closure 32 closes the passageway of the intestines 4.Thus, the constriction elements 33A, 33B at least partially constrictthe selected portion to at least substantially decrease thecross-sectional area of the passageway of the intestines 4, when thepump 31 is not in operation (FIG. 177B), and the electrodes electricallystimulate muscle or neural tissue of the intestines to cause contractionof the intestines, so that the intestinal wall thickens, to completelyclose the passageway of the intestines 4. The electrodes may beactivated in accordance with the preset scheme described above inconnection with the embodiment of FIGS. 171A-171D, or in accordance withany other determined pattern or scheme that causes variation of thestimulation of the intestine.

FIG. 178A shows another embodiment of the invention including anartificial intestinal piece 34 implanted in a colostomy patient providedwith a stoma 35. The small intestines 19 is surgically cut to form anupstream open end 36 thereof and a downstream open end 37 of a shortseparated piece 39 of the small intestines 19 that forms the stoma 35.The short piece 39 of the intestines 19 extends through a surgicallycreated opening in the patient's abdominal wall 39A. The artificialintestinal piece 34 is surgically joined to and integrated with thepatient's small intestines 19 between the upstream end 36 and downstreamend 37. Blood vessels 38 of a portion of the patient's mesentery supplyblood to the separate piece 39 of the intestines that forms the stoma35. The artificial intestinal piece 34 is provided with a pump 40, whichincludes a constriction device that only operates on the artificialintestinal piece 34. A holder 40A attached to the pump 40 is secured tothe abdominal wall 39A at the opening thereof. The constriction deviceof pump 40 alternately constricts and releases the artificial intestinalpiece 34, which may include an elastic tubing, so that intestinalcontents is discharged through the patient's stoma 35. The constrictiondevice of pump 40 may be selected from any one of the variousconstriction devices described in the embodiments of the presentapplication. In the embodiment of FIG. 178A, the constriction device mayconstrict the artificial intestinal piece 34 to normally keep thepassageway thereof closed, when the pump 40 is not in operation. Also,any kind of pump that is capable of constricting the small intestinesmay be used in the embodiment of FIG. 178A.

The artificial intestinal piece 34 or 43 described above mayalternatively be joined directly or indirectly to the patient's anus, asillustrated in FIG. 178B.

FIG. 179 is an enlarged view of the artificial intestinal piece 34 andthe pump 40 showing how the intestinal piece 34 with the pump 40 issealed to the intestines 19 at the upstream and downstream ends 36, 37thereof. Thus, a fabric tubular net 41 is applied on the intestines 19at the upstream end 36 thereof and is attached to the pump 40. Anotherfabric tubular net 42 is applied on the separate piece 39 of theintestines 19 and is attached to the pump 40. The tubular net 42 has notbeen fully applied on the separate piece 39 to illustrate how the net 42is rolled on the piece 39. Initially the fabric nets 41 and 42 aresutured to the intestines, normally with absorbable sutures. The tubularnets 41, 42 promote ingrowth of fibrotic tissue that seals theintestines 19 to the artificial intestinal piece 34. Another materialsuch as PTFE, silicone or polyurethane may be applied externally on thetubular nets 41, 42.

FIG. 180 shows a modification of the embodiment of FIG. 179, whichincludes an artificial intestinal piece 43 having a tubular portion 44that extends from the pump 40 at the downstream side thereof and forms astoma 45. Another tubular portion 44A of the artificial intestinal piece43 extends from the pump 40 at the upstream end thereof. With thismodification there is only need for surgically joining and sealing thetubular portion 44A of the artificial intestinal piece 43 to thepatient's small intestines 19.

FIGS. 181A, 181B, 181C and 181D schematically illustrate differentstages of operation of another embodiment of the invention, wherein apump 46 includes a constriction device 47 that axially constricts apatient's intestines 19. Referring to FIG. 181A, the constriction device47 includes a first pair of constriction elements 48A and 48B hinged toeach other and a second pair of constriction elements 49A and 49B hingedto each other. The two pairs of constriction elements 48A, 48 b and 49A,49B are joined to a selected portion of the intestines 19 at oppositesides thereof by means of a material 50 that allows ingrowth of fibrotictissue. FIG. 181B shows how the first pair of constriction elements 48A,48B and the second pair of constriction elements 49A, 49B have beenmoved away from each other to radially expand the selected portion ofintestines 19 to form an expanded chamber 51 of the passageway ofintestines 4. FIG. 181C shows how the constriction elements 48A and 49Bare turned towards each other to radially and axially constrict theselected portion of intestines 19, whereby the volume of the chamber 51is reduced causing intestinal contents to displace through thepassageway of the intestines and out of intestines 19. FIG. 181D showshow also the constriction elements 48B and 49B of the second pair areturned towards each other, to axially constrict the expanded selectedportion to further reduce the volume of the chamber 51, whereby moreintestinal contents is displaced through the passageway of intestines 4and out of intestines 19.

FIG. 181E illustrates the embodiment of FIG. 181D including an electricstimulation device having the same purpose as the electric stimulationdevice described above in connection with the embodiment according toFIGS. 166A-166C. The stimulation device of FIG. 181E includes electrodes16 positioned on the constriction elements 48A, 48B, 49A and 49B. Theelectrodes 16 electrically stimulate the intestines 19 to causecontraction and thickening of the intestinal wall at the same time asthe constriction elements 48A, 48B, 49A and 49B axially constricts theintestines 19.

FIGS. 182-185 show another embodiment of the invention, wherein amanually operable pump 52 includes a hydraulically operated constrictiondevice 53 applied on a selected portion of the patient's intestines 19.The constriction device 53 includes a first sub-device 54 forconstricting and releasing the selected portion at an upstream endthereof, a second sub-device 55 for constricting and releasing theselected portion at a downstream end thereof, and a third sub-device 56for constricting and releasing the selected portion between the upstreamand downstream ends thereof. The first sub-device 54 includes a frame57, a constriction element 58 movable relative to the frame 57 and ahydraulic bellows 59 connected between the frame 57 and the constrictionelement 58. A support surface 60 of the frame 57 supports the intestine19, so that the constriction element 58 can constrict the intestine 19against the support surface 60, see FIG. 183. The second sub-device 55includes two constriction elements 61A and 61B positioned at oppositesides of the intestine 19 and two bellows 62A and 62B also positioned atopposite sides of the Intestine 19 and interconnecting the constrictionelements 61A, 61B, see FIG. 184. The third sub-device 56 is designedsimilar to the first sub-device 54 and includes a frame 63, an elongateconstriction element 64 movable relative to the frame 63 and twohydraulic bellows 65A and 65B connected between the frame 63 and theelongate constriction element 64. A support surface 66 of the frame 63supports the intestine 19. The bellows 59, 65A, 65B, 62A, 62B aredimensioned, such that when they are fully expanded, the volume of thebellows 59 is equal to the volume of the two bellows 62A and 62B,whereas the volume of the two bellows 65A and 65B is larger than thevolume of the bellows 59 and larger than the volume of the bellows 62Aand 62B.

An actuator in the form of a manually compressible elastic reservoir 67containing a volume of hydraulic fluid is subcutaneously Implantable inthe patient's body and hydraulically connected to the respective bellows59, 65A, 65B, 62A and 62B via hydraulic conduits 68A, 68B, 68C, 68D and68E of equal size. Conduit 68C branches hydraulic fluid supplied throughthe single conduit 68E to the two bellows 65A and 65B. FIGS. 182-184show the pump 52 in an inactivated state, in which the reservoir 67 isuncompressed, whereby all of the bellows 59, 65A, 65B, 62A, 62B areretracted. As a result, the sub-device 55 constricts the intestine 19 atthe downstream end of the selected portion (see FIG. 184), whereas thesub-devices 54 and 56 release the intestine 19.

FIGS. 185-187 show the pump 52 in an activated state, in which thepatient manually compresses the reservoir 67 to distribute hydraulicfluid from the reservoir 67 to the bellows 59, 65A, 65B, 62A, 62B. As aresult, the bellows 59 expands so that the short constriction element 58constricts the intestine 19 and closes the passageway of the intestines4 at the upstream end of the selected portion of the intestine 19 (seeFIG. 186), the two bellows 62A, 62B expand so that the shortconstriction elements 61A, 61B release the intestine 19 and open thepassageway of the intestines 4 at the downstream end of the selectedportion (see FIG. 187), and the two bellows 65A, 65B expand so that theelongate constriction elements 64 constrict the selected portion betweenthe upstream and downstream ends thereof, whereby intestinal contents isdisplaced in the passageway of the intestines 4. Since the bellows 59has a smaller volume when expanded than the combined volume of the twobellows 65A, 65B and hydraulic fluid is supplied to the bellows 65A, 65Bvia the single conduit 68E, the bellows 59 expands more quickly than thebellows 65A, 65B, when the reservoir 67 is compressed. (This differencein the rate of expansion may alternatively be achieved by designingbellows 59 with a smaller volume than the volume of each one of bellows65A and 65B, and connecting bellows 65A to conduit 68B and bellows 65Bto conduit 68D.) Consequently, the constriction element 58 closes thepassageway of the intestines 4 at the upstream end of the selectedportion of the intestine 19 well before the elongate constrictionelement 64 fully constricts the intestines, whereby a significant amountof intestinal contents in the selected portion of the intestine 19 isforced downstream in the passageway of the intestines as theconstriction element 64 constricts the intestine 19. When the patientceases to compress the reservoir 67, the reservoir resumes itsuncompressed shape sucking hydraulic fluid from the bellows 59, 65A,65B, 62A, 62B, whereby the bellows 59, 65A, 65B, 62A, 62B retract andthe pump 52 returns to the inactivated state shown in FIG. 182.

The hydraulic operation means of the constriction device according toFIGS. 182-184 described above may also be implemented in theconstriction devices of the embodiments according to FIGS. 1-10C and inthe closure of the embodiment according to FIGS. 177A, 177B.

FIGS. 188A and 188B show a hydraulic reverse servo 69 suited for use inthe embodiment of FIGS. 182-187. The reverse servo 69 includes arectangular housing 70 with two parallel long sidewalls 71A and 71B andtwo parallel short sidewalls 72A and 72B. A movable wall 73 parallelwith the long sidewalls 71A, 71B slides on the short sidewalls 72A, 72Bbetween the long sidewalls 71A, 71B. A relatively large, substantiallycylindrical bellows reservoir 74 defining a chamber 75 extends betweenand is joined to the movable intermediate wall 73 and the long sidewall71B, and a relatively small, substantially cylindrical bellows reservoir76 defining a chamber 77, which is substantially smaller than thechamber 75 of the large reservoir 74, extends between and is joined tothe movable wall 73 and the long sidewall 71A. The small bellowsreservoir 76 has a fluid supply pipe 78 for connection to thecompressible reservoir 67 through the conduit 68A and the large bellowsreservoir 74 has a fluid supply pipe 79 for connection to the bellows59, 65A, 65B, 62A, 62B through the conduits 68B-68D.

Referring to FIG. 188A, when the patient compresses the reservoir 67, asmall amount of hydraulic fluid is conducted from the reservoir 67through the supply pipe 78 into the chamber 77 of the small bellowsreservoir 76, so that the small bellows reservoir 76 expands and pushesthe movable intermediate wall 73 towards the long sidewall 71B. As aresult, the large bellows reservoir 74 is contracted by the intermediatewall 73 against the long sidewall 71B, whereby a large amount ofhydraulic fluid is forced out of the chamber 75 of the large bellowsreservoir 74 through the supply pipe 79 and further through the conduits68B-68D into the bellows 59, 65A, 65B, 62A, 62B of the pump 52, see FIG.188B.

FIGS. 189A and 189B show a mechanically operated constriction device 80,which may be implemented in the embodiments according to FIGS. 163-172Cand 177A, 177B. The constriction device 80 includes an open endedtubular housing 81 applied on a selected portion of a patient'sintestine 19, and a constriction element 82, which is radially movablein the tubular housing 81 towards and away from the intestine 19 betweena released position, see FIG. 189A, and a constricted position, see FIG.189B, in which the constriction element 82 constricts the selectedportion of the intestines 19. Mechanical operation means formechanically operating the constriction element 82 includes an electricmotor 83 attached to the housing 81 and a telescopic device 84, which isdriven by the motor 83 and operatively connected to the constrictionelement 82. When the motor 83 is powered, it expands the telescopicdevice 30 so that the constriction element 82 constricts the intestine19 and closes the passageway of the intestines 4, see FIG. 288. When theconstriction element 82 is to release the intestine 19, the electricmotor 83 is reversed so that the telescopic device 84 retracts theconstriction element 82 to the position shown in FIG. 189A, whereby theintestine 19 is released and the passageway of the intestines 4 is open.

Alternatively, the mechanical operation means may include asubcutaneously implanted actuator operatively connected to clampingelement 82, wherein the actuator is manually operated by the patient, asshown in FIG. 189C. Thus, the motor 83 is replaced by a spring 84 aacting to keep the telescopic device 84 expanded to force the clampingelement 82 against the intestine 19. The actuator includes a levermechanism 83 a that is operatively connected to the telescopic device84. The patient may push through the skin the lever mechanism 83 a topull the telescopic device 84 against the action of the spring 84 a tothe retracted position of the telescopic device 84, as indicated inphantom lines. When the patient releases the lever mechanism 83 a, thespring 84 a expands the telescopic device 84, whereby clamping element82 is forced back against the intestine 19.

The mechanical operation means, as described above in connection withFIGS. 189A, 189B and 189C, may also be implemented in the embodimentsaccording to FIGS. 163A-172C and 177A-180.

FIG. 190 illustrates the pump 11 of the embodiment of FIGS. 168A and168B applied on the intestines of a stoma patient, wherein theconstriction elements 15A, 15B of the constriction device 12 constrictthe Intestines 19 and the electrodes 16 are energized to close thepassageway of the intestines 4. A control device includes an externalcontrol unit in the form of a wireless remote control 85A, and animplanted internal control unit 86, which may include a microprocessor,for controlling the pump 11. The remote control 85A is operable by thepatient to control the internal control unit 86 to switch on and off thepump 11. A separate wireless energy transmitter 85B, which alternativelymay be integrated with the remote control 85A, is adapted to transmitwireless energy from outside the patient's body to an implantedenergy-transforming device 87 that transforms the transmitted wirelessenergy into electric energy. An implanted rechargeable battery 88 forpowering the pump 11 and for energizing the electrodes 16 stores theelectric energy produced by the energy-transforming device 87. Thecontrol unit 86, energy-transforming device 87 and battery 88 areimplanted as a package in the patient's fat layer between the skin andthe abdominal wall. The pump 11 may also be directly powered with theelectric energy, as the energy-transforming device 87 transforms thewireless energy transmitted by the wireless energy transmitter 85B intothe electric energy. The wireless energy may comprise electromagneticwaves emitted by a coil of the energy transmitter 85B, wherein acorresponding coil of the energy-transforming device 87 transforms theelectromagnetic waves into a current.

An implanted sensor 89 senses a physical parameter of the patient, suchas the volume of the intestinal contents in the selected portion of theintestines or the distension of or the pressure in the intestines 19.The remote control 85A is adapted to produce an indication, such as asound signal or displayed information, in response to the sensor sensinga value of the physical parameter exceeding a threshold value, when thepump 11 is not in operation. This indication should pay attention to thepatient when it is time to defecate.

FIG. 191 illustrates the pump 11 of the embodiment of FIGS. 168A and168B applied on a colostomy patient's small intestines 19 surgicallyconnected to the patient's anus.

A general method for controlling transmission of wireless energy toimplanted energy consuming components of the apparatus of the presentinvention will be defined in general terms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal source of energy located outside the patient and is received byan internal energy receiver located inside the patient, the internalenergy receiver being connected to the implanted energy consumingcomponents of the apparatus for directly or indirectly supplyingreceived energy thereto. An energy balance is determined between theenergy received by the internal energy receiver and the energy used forthe operation of the implanted parts of the apparatus. The transmissionof wireless energy E from the external source of energy is thencontrolled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external source of energy to a secondary coil in the internalenergy receiver. A change in the energy balance may be detected tocontrol the transmission of wireless energy based on the detected energybalance change. A difference may also be detected between energyreceived by the internal energy receiver and energy used for theoperation of the implanted parts of the apparatus, to control thetransmission of wireless energy based on the detected energy difference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the operation of the implantedparts of the apparatus be consumed to operate the implanted parts of theapparatus and/or stored in at least one implanted energy storage deviceof the apparatus.

When electrical and/or physical parameters of the implanted parts of theapparatus and/or physical parameters of the patient are determined, theenergy may be transmitted for consumption and storage according to atransmission rate per time unit which is determined based on saidparameters. The total amount of transmitted energy may also bedetermined based on said parameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external source of energymay be controlled by applying to the external source of energyelectrical pulses from a first electric circuit to transmit the wirelessenergy, the electrical pulses having leading and trailing edges, varyingthe lengths of first time intervals between successive leading andtrailing edges of the electrical pulses and/or the lengths of secondtime intervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external sourceof energy may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

The embodiments also identify general features for controllingtransmission of wireless energy to implanted energy consuming componentsof the apparatus of the present invention. Such features of theapparatus will be defined in general terms in the following.

In its broadest sense, the apparatus comprises a control device forcontrolling the transmission of wireless energy from anenergy-transmission device, and an implantable internal energy receiverfor receiving the transmitted wireless energy, the internal energyreceiver being connected to implantable energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. The apparatus further comprises a determination device adaptedto determine an energy balance between the energy received by theinternal energy receiver and the energy used for the implantable energyconsuming components of the apparatus, wherein the control devicecontrols the transmission of wireless energy from the externalenergy-transmission device, based on the energy balance determined bythe determination device.

Further, the apparatus of the invention may comprise any of thefollowing features:

-   -   A primary coil in the external source of energy adapted to        transmit the wireless energy inductively to a secondary coil in        the internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change.    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for implanted parts of the apparatus is consumed        to operate the implanted parts, and/or stored in at least one        energy storage device of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIG. 192a shows a system, wherein the reservoir 140 is formed by aplurality of bent portions of human intestine 70, with laterallyadjacent sections thereof being cut open along their mutual contact lineand the resulting upper halves and lower halves thereof beinginterconnected so as to form walls of a reservoir 140. Theinterconnection can advantageously be made with staplers, possiblyincluding bonding with a biocompatible glue, but sewing is likewise anoption.

At the exit of the reservoir 140, cooperating exit valves 61, 62, 63 areprovided along a non-modified terminate section 80 of the patient'snatural intestine 70. The terminate section 80 exits the patient'sabdominal wall 101 through a surgically created stomy 170. The valves61, 62, 63 each comprise an electrical stimulation device adapted toelectrically stimulate muscle or neural tissue of the intestine 70 so asto cause at least partial contraction of the intestine. Electricalstimulation is achieved by applying electrical pulses to the intestinesection 80. Each of the valves 61, 62, 63 further comprises at least oneconstriction device. As shown in FIG. 192a , the constriction devices ofthe valves 61, 62, 63 only partly constrict the patient's intestine 70,whereas the electrical stimulation devices of the valves are adapted tofurther constrict the respective sections so that flow through theterminate section is completely prevented. In FIG. 192a the electricalstimulation device of the valve 62 completely constricts this respectivesection of the patient's intestine. Closing is preferably achieved bystimulating the different sections in a wave-like manner in a directionopposite to the natural intestine contents flow. Since the electricalstimulation always occurs for a short time period on each section of theintestine, the valves 61, 62, 63 allow for gentle constriction of theintestine's terminate section 80 at the exit of the reservoir, so thatthe exit is normally kept closed.

Instead of the electrical stimulation devices combined with theconstriction devices, the valve at the exit of the reservoir 140 may beformed only by one or possibly more constriction devices.

In the situation shown in FIG. 192a , in which the valves 61, 62, 63close the exit of the reservoir 140, an entry valve in the form of acuff 194 at the entrance of the reservoir 140 is open to allowintestinal contents to flow into the reservoir 140. In this embodiment,the cuff 194 is a hydraulic device which is connected to a hydraulicreservoir 195 supplying the cuff 194 with hydraulic fluid when the entryvalve is to be closed. The pump and control for filling and emptying thehydraulic reservoir 195 are not specifically shown and are synchronizedwith the functions of the other valves of the system.

When the reservoir 140 is to be emptied, the valves 61, 62, 63 areopened to release the patient's intestine 70 at the exit of thereservoir as shown in FIG. 192b . At the same time, the cuff 194 issupplied with hydraulic fluid so as to completely constrict theintestine 70 at the entrance of the reservoir 140. In this manner, thereservoir 140 can be emptied without additional intestinal contentsflowing into the reservoir 140. Advantageously, the valves 61, 62, 63may support emptying of the reservoir 140 constricting the differentsections of the terminate section 80 in a wave-like manner in thedirection towards the stomy 170. Alternatively, an exit valve may beprovided adapted to be arranged downstream from the reservoir 140 so asto receive a conduit inserted from outside the patient's body into thepatient's intestine, thereby mechanically urging the exit valve to openwhen emptying of the reservoir 140 is desired. Such conduit provides aflow passage to an external collecting device comprising a suction pumpadapted to empty the reservoir.

In the following, different embodiments of the system for emptying thereservoir 140 are described.

As shown in FIG. 193A, the reservoir 140 may be emptied by means ofstimulation devices 160 which are adapted to electrically stimulatemuscle or neural tissue of the reservoir so as to cause at least partialcontraction of the reservoir 140. This is a very gentle way ofconstricting the tissue. A second set of stimulation devices 161 isarranged at the opposite side of the reservoir 140 as shown in FIG. 101b. In this embodiment, the stimulation devices 160, 161 are thus arrangedsubstantially in two planes at opposite sides of the reservoir 140. Thestimulation devices 160, 161 preferably comprise at least one electrodeadapted to apply electric pulses to the reservoir 140. The stimulationdevices 160, 161 have a longitudinal shape so as to span over thereservoir 140 when arranged side by side as shown in FIG. 101a . Theoverall spanned area would typically be larger than 10 cm×10 cm in planview.

As shown in FIG. 193A, the stimulation devices 160 have a longitudinalor rod-like shape so as to substantially cover the width of thereservoir 140. They may each comprise one longitudinal electrode, orthey may each comprise several electrodes that are arranged in series oneach stimulation device 160 and can preferably be controlledindividually. In another embodiment, the stimulation devices 160 may beplate-like members having a larger width than those shown in theembodiment of FIG. 193A, resulting in a decreased number of stimulationdevices. Furthermore, instead of arranging the stimulation devicesseparately side by side, they may also be combined in one integral unit,such as a plate, on one or each opposing side of the reservoir. In casethat the stimulation device or devices have an enlarged width, aplurality of electrodes may be arranged in parallel on the stimulationdevices. The plate-like or rod-like stimulation devices may be embeddedin a flexible web to facilitate implantation and relative fixation ofadjacent stimulation devices.

In another preferred embodiment, the stimulation devices 160, 161 areembedded in surgically created folds or invaginations 141 in theintestinal wall of the reservoir 140, as shown in FIGS. 194A, 194B. Byproviding invaginations 141 in the reservoir 140, the stimulationdevices 160, 161 are substantially surrounded by tissue of the reservoir140 and thus contact surface is increased. Stimulation of the reservoir140 can thus be improved. Furthermore, by this way of implantation,surrounding tissue in the abdominal cavity is not contacted by theelectrodes and thus not influenced by the stimulation. Fixation of thestimulation devices 160, 161 is also improved, thus enabling thestimulation devices 160, 161 to be precisely located over long time. Inthis embodiment, the stimulation devices 160, 161 necessarily follow themovement of the wall of the reservoir 140, in particular the stimulationdevices 160, 161 approach while intestinal contents are released fromthe reservoir 140.

The stimulation devices 160, 161 are specifically adapted to stimulate,over time, the different portions of the reservoir 140 in a consecutiveor wave-like manner in a direction towards the exit valve 61, 62, 63 orstomy 170 (or anus) to cause the reservoir 140 to be emptied. Thus,different portions of the reservoir 140 can be constricted bystimulation at different times in any predetermined stimulation pattern.This allows for adapting the arrangement of the stimulation devices 160,161 and their mode of operation to the individual form of the reservoir140. This functionality is further enhanced where each of thestimulation devices carries 160, 161 a plurality of electrodes that arecontrolled individually or in groups.

Emptying of the reservoir 140 can be activated by the patient pushing asubcutaneously arranged, manually operable actuator 99 in the abdominalwall 101 connected to an energy storage means and/or controller 150. Thestimulation devices 160, 161 are controlled and/or supplied with energyby means of the energy storage means and/or controller 150.

When the cuff 194 is closed during emptying the reservoir, allstimulation devices 160, 161 may stimulate the reservoir 140 at the sametime or, as mentioned before, in a consecutive or wave-like manner, tocause the entire reservoir to constrict. Since the cuff 194 is closed,the content of the reservoir 140 is urged to flow in the directiontowards the stomy 170 (or anus).

Alternatively, or even in addition to the electrical stimulation device160, 161, a constriction device may be provided implanted in thepatient's body for constricting the reservoir 140 mechanically orhydraulically from outside the intestinal wall of the reservoir 140.Examples of mechanical and hydraulic constriction devices will bedescribed in more detail hereinafter in relation to FIGS. 195A, 195B andFIGS. 196A, 196B. Where the stimulation device is combined with theconstriction device, the stimulation device and the constriction devicepreferably act on the portion of the same reservoir 140. In that case,it is advantageous if the constriction device constricts the portion ofthe reservoir 140 only partly, in order not to damage the intestine.Further constriction is achieved by simultaneous electrical stimulation.

In addition, when constriction of the reservoir 140 caused by theconstriction device is released, the stimulation device may, ifaccordingly adapted, be used to pump intestinal contents towards theexit of the reservoir 140 by, over time, stimulating different portionsof the intestinal wall of the reservoir 140 in a wave like manner in adirection of natural intestinal contents flow. In this way, filling ofthe reservoir 140 is supported, since intestinal contents do not remainin the area of the entrance of the reservoir 140 but are transported inthe direction towards the exit.

FIGS. 195A, 195B show an embodiment comprising mechanically actingmembers in the form of rollers 180, 181 for emptying the reservoir 140.The rollers 180, 181 are arranged on opposite sides of the reservoir 140and have a length spanning the entire width of the reservoir 140. Theyare each guided by two tracks 182 a, 183 a and 182 b, 183 b,respectively, and are driven by a motor integrated in the rollers (notshown) which preferably comprises a servo drive. The servo drive reducesthe force required to move the rollers 180, 181. The tracks 182 a, 183a, 182 b, 183 b are arranged in pairs on opposite sides of the reservoir140. As shown in FIG. 195B, the tracks have bent end portions 184 a, 184b directed away from the reservoir 140 so as to allow the rollers 180,181 to assume an inactive position in which they do not constrict thereservoir 140. Upon emptying, the rollers 180, 181 are driven along thetracks in the direction of the arrows, thereby coming closer to eachother and constricting the reservoir 140. The rollers are further drivenalong the length of the reservoir in their proximate position guided bythe tracks and mechanically squeeze intestinal contents in the directiontowards the exit of the reservoir 140. When the rollers 180, 181 havereached their final position and the reservoir 140 is emptied, they arereturned to their initial inactive position at the end portions 184 a,184 b of the tracks. Instead of rollers on each side of the reservoir140, it can be sufficient to provide one or more rollers only on oneside of the reservoir 140 and place a counteracting plate on therespective other side of the reservoir 140.

In a further embodiment shown in FIGS. 196A, 196A, emptying of thereservoir 140 is carried out by means of a hydraulically acting member190 acting on the intestinal wall of the reservoir 140 from the outsidethereof. The hydraulically acting member 190 is connected to anartificial reservoir 193 supplying the hydraulically acting member 190with hydraulic fluid and having a sufficient size to contain hydraulicfluid corresponding to the volume of the reservoir 140. The artificialreservoir 193 has a flexible wall to allow the hydraulic fluid to bedrawn off from the artificial reservoir 193. The hydraulically actingmember 190 is of flexible material and may be tube-like or bag-like soas to accommodate the reservoir 140 therein. As shown in FIG. 104b , thereservoir 140 is surrounded by the hydraulically acting member 190. Thehydraulically acting member 190 is divided into a plurality of chambers,wherein a first chamber 191 and a last chamber 194 are connected to theartificial reservoir 193 by hydraulic pipes. The chambers areinterconnected by connections 192, which may be simple holes acting as athrottle or which may include a valve.

Upon activating emptying of the reservoir 140 by pushing the button 99,hydraulic fluid is supplied to the first chamber 191. The subsequentchambers are supplied with hydraulic fluid through connections 192 thuscausing the hydraulically acting member 190 to be filled from the firstchamber 191 to the last chamber 194. The filling of the chambers occurssequentially, with the next following chamber starting to fill beforethe foregoing chamber is filled completely. In this manner, intestinalcontents are hydraulically squeezed out in the direction towards theexit of the reservoir 140. When the hydraulically acting member 190 iscompletely filled with hydraulic fluid, the reservoir 140 completelyconstricted. The hydraulic fluid is then retracted from thehydraulically acting member 190 to the artificial reservoir 193 usingnegative pressure so as to allow the reservoir 140 to fill up again.

In another embodiment, each chamber may have a separate connection tothe artificial reservoir 193 in order to be able to be filledindividually. The reservoir 140 may be emptied by consecutively fillingtwo adjacent chambers, i.e. filling the first and second chamber, thenemptying the first chamber while filling the third chamber, thenemptying the second chamber while filling the fourth chamber, and soforth. In this manner intestinal contents are squeezed towards the exitof the reservoir 140.

Alternatively, instead of applying a negative pressure for evacuatingthe chambers, at least one valve, preferably two valves, may be provided(not shown) between the hydraulically acting member 190 and theartificial reservoir 193 which, when in an appropriate operationalposition, allows hydraulic fluid to passively flow from the chambersback into the artificial reservoir 193 when the reservoir 140 fills withintestinal contents and which, when in an appropriate other position,allows hydraulic fluid to be pumped from the artificial reservoir intothe chambers.

As in all embodiments, emptying of the reservoir 140 is coordinated withthe opening and closing of the entry and exit valves 194, 61, 62, 63.

FIG. 197a shows a reservoir 140 formed from human intestine 70. Aplurality of bent portions of the human's intestine 70 is cut open alongthe mutual contact lines of laterally adjacent sections thereof. Theresulting upper halves and lower halves are interconnected so as to formthe walls of the intestinal reservoir 140. The interconnection canadvantageously be made with staplers, possibly including bonding with abiocompatible glue, but sewing is likewise an option.

At the exit of the intestinal reservoir 140, an exit valve comprising aplurality of valve sections 61, 62, 63 is provided along and encloses anon-modified terminate section 80 of the patient's intestine. Thenon-modified terminate section 80 is passed through the patient'sabdominal wall 101 and forms a surgically created stoma 170. Thenon-modified terminate section 80 could like-wise lead to the patient'srectum or anus. The valve sections 61, 62, 63 each comprise anelectrical stimulation device adapted to electrically stimulate muscleor neutral tissue of the intestine's terminate section 80 so as to causeat least partial contraction of the terminate section. Electricalstimulation is achieved by applying electrical pulses to the terminatesection 80 by means of electrodes (not shown). Each of the valvesections 61, 62, 63 further comprises at least one constriction device.

In FIG. 197A the constriction devices of all three valve sections 61,62, 63 are activated. As can be seen, the constriction devices 61, 62,63 only partly constrict the intestine's terminate section 80 so thatblood circulation in the tissue of the intestinal wall is not negativelyaffected thereby. The electrical stimulation devices of the valvesections 61, 62, 63 are adapted to further constrict the terminatesection 80 so that flow through the terminate section 80 is completelyprevented. However, only one electrical stimulation device is activatedat a time. In the situation shown in FIG. 197A, the central valvesection 62 is currently activated so as to stimulate and therebycompletely constrict the corresponding section of the intestine'sterminate section 80. While instead of the three stimulation devicesshown, a single stimulation device would be sufficient for opening andclosing the intestine, the arrangement of the plurality of stimulationdevices allows to stimulate different sections of the intestine'sterminate section 80 over time. The function of the three stimulationdevices may also be combined in one integral unit. Since the electricalstimulation in each valve section 61, 62, 63 always occurs for a shorttime period only, the respective other, non-stimulated sections of theintestine's terminate section 80 have time to recover from a previousconstriction so that sufficient blood flow within the intestinal wall isensured. All in all, the valve sections 61, 62, 63 allow for gentleconstriction of the intestine's terminate section 80 at the exit of thereservoir when keeping the exit normally closed. Most preferably,closing is achieved by stimulating different sections of the intestine'sterminate section 80 in a wave-like manner in a direction opposite tothe natural intestine contents flow.

However, instead of combining electrical stimulation devices with aconstriction device, the valve at the exit of the reservoir 140 may onlybe formed by one or a plurality of constriction devices. Theconstriction device is preferably of the hydraulic type, such as in theform of pressure cuffs, but may also be of the mechanical type. Theconstriction device is not described here in more detail, and maycorrespond to the entry valve 194 provided at the entry of the reservoir140. The entry valve 194 here has the form of a hydraulic cuff. Whilethe valve sections 61, 62, 63 of the exit valve are provided to normallyclose the exit of the intestinal reservoir 140 in order to keepintestinal contents inside the reservoir 140, the entry valve 194 isnormally open to allow intestinal contents to flow into the reservoir140.

The cuff of the entry valve 194 can be filled with a hydraulic fluidfrom an artificial hydraulic reservoir 195 so as to completely constrictthe intestine 70 in front of the reservoir 140. This way, backflow ofintestinal contents into the intestine 70 may effectively be prevented,when emptying of the reservoir is desired. At the same time, the valvesections 61, 62, 63 of the exit valve are opened to allow emptying ofthe intestinal reservoir 140. This is shown in FIG. 197B. As can beseen, the partial constriction of the terminal section 80 by means ofthe constriction devices has been released. Also, electrical stimulationpulses are no longer applied. However, it can be advantageous to supportthe emptying process by constricting the different sections of theintestine's terminate section 80 in a wave-like manner in a directiontowards the stoma 170 by means of the valve sections 61, 62, 63 of theexit valve.

In the following, different embodiments of a system for emptying theintestinal reservoir 140 are described.

As shown in FIG. 198A, an electrical stimulation apparatus withelectrode-carrying holding devices 160 which are adapted to electricallystimulate muscle or neural tissue of the intestinal reservoir 140 so asto cause at least partial contraction of the reservoir 140. This is avery gentle way of constricting the tissue of the intestinal reservoir140. A second set of electrode-carrying holding devices 161 is arrangedon the opposite side of the reservoir 140, as can be seen in FIG. 198B.Thus, the electrodes of the holding devices 160, 161 are arrangedsubstantially in two planes at opposite sides of the reservoir 140. Theholding devices 160, 161 have a longitudinal shape so as to span overthe reservoir 140 when arranged side by side as shown in FIG. 198A.

As shown in FIG. 198A, the holding devices 160, 161 each have alongitudinal or rod-like shape substantially spanning the entire widthof the reservoir 140. The length is preferable 5 cm or longer, dependingon the size of the intestinal reservoir, and cane even have a length ofmore than 8 cm or even more then 10 cm. The overall spanned area wouldtypically be larger than 4.5 cm×6 cm in plan view. The holding devices160, 161 may each comprise a row of electrodes arranged along the lengththereof and adapted to apply electric pulses to the intestinal wall ofthe reservoir 140. Alternatively, each holding device may substantiallyconsist of only one longitudinal electrode. Preferably, the electrodescan be controlled individually.

In another embodiment, not shown, the stimulation devices 160, 161 mayform plate-like members having a larger width than those shown in FIG.198A, resulting in a decreased number of holding devices. In an evenfurther embodiment, likewise not shown, instead of arranging the holdingdevices separately side by side, they may be combined in an integralunit, such as a plate, on one side or on opposing sides of theintestinal reservoir. In case that the holding device or devices formplate-like members with an enlarged width, a plurality of electrode rowsmay be arranged in parallel on the holding devices. The plate-like orrod-like holding devices may be embedded in a flexible web (not shown)to facilitate implantation and relative fixation of adjacent stimulationdevices.

Emptying of the intestinal reservoir 140 can be activated by the patientpressing a manually operable actuator 99 subcutaneously implanted in thepatient's abdominal wall 101 in the form of a switch. The actuator 99 isconnected to a combined energy storage means and controller device 150.The electrodes placed on the holding devices 160, 161 are controlled andsupplied with energy via the energy storage means and controller device150. The device 150 is connected to the holding devices 160, 161 viaindividual lines.

Under the control of the device 150, different portions of theintestinal wall of the reservoir 140 are stimulated at different timesin a predetermined stimulation pattern by means of the electrodes of theholding devices 160, 161 and, thus, different sections of the intestinalreservoir 140 are constricted by such stimulation. The electricalstimulation type pump is specifically adapted to stimulate, over time,respectively adjacent portions of the intestinal wall of the reservoir140 in a consecutive or wave-like manner in a direction towards thestoma 170 (or rectum/anus) to cause the reservoir 140 to be emptied.This structure allows for adapting the arrangement of the holdingdevices 160, 161 and their mode of operation to the individual form ofthe intestinal reservoir 140. This functionality is further enhancedwhere each of the holding devices 160, 161 carries a plurality ofelectrodes that are controlled individually or in groups.

As stated before, the entry valve 194 is preferably closed during theemptying of the reservoir. This is particularly important in case thatall holding devices 160, 161 are activated simultaneously so as toconstrict all sections of the reservoir 140 at the same time. Since theexit valve 194 is closed, intestinal contents cannot flow back from thereservoir into the patient's intestine but are urged towards the exit ofthe reservoir. An entry valve is not specifically needed when theelectrode-carrying holding devices are activated in a consecutive orwave-like manner, as mentioned before.

In another embodiment shown in FIGS. 199A and 199B, theelectrode-carrying holding devices 160, 161 are specifically providedfor being embedded in folds or invaginations 141 surgically created inthe intestinal wall of the reservoir 140. By providing the invaginations141 in the reservoir 140, the holding devices 160, 161 are substantiallysurrounded by tissue of the reservoir 140 and, thus, contact area isincreased. Stimulation of the reservoir 140 can thus be improved.Furthermore, surrounding tissue in the abdominal cavity is not contactedby the electrodes of the holding devices and, thus, not influenced bythe stimulation process. Fixation of the holding devices 160, 161 isalso improved, thereby ensuring that the holding devices 160, 161 and,thus, the electrodes are precisely located over long time. The holdingdevices 160, 161 necessarily follow all movements of the intestinal wallof the reservoir 140.

Alternatively, or even in addition to the electrical stimulation typepump, a constriction type pump may be implanted in the patient's bodyfor constricting the reservoir 140 mechanically or hydraulically fromoutside the intestinal wall of the reservoir 140. Examples of mechanicaland hydraulic constriction type pumps will be described in more detailhereinafter in relation to FIGS. 200A, 200B and FIGS. 201A, 201B. Wherethe stimulation type pump is combined with a constriction type pump, thetwo pumps preferably act on the same portion of the reservoir 140. Inthat case, it is advantageous if the constriction type pump constrictsthe respective portion of the reservoir 140 only partly, in order not todamage the intestine, whereas further constriction is achieved bysimultaneous electrical stimulation of the same portion.

In addition, when constriction of the reservoir 140 caused by theconstriction type pump is released, the stimulation type pump may, ifaccordingly adapted, be used to pump intestinal contents towards theexit of the reservoir 140 by, over time, stimulating different portionsof the intestinal wall of the reservoir 140 in a wave-like manner in adirection of natural intestinal contents flow. In this way, filling ofthe reservoir 140 is supported, since intestinal contents do not remainin the area of the entrance of the reservoir 140 but are transported inthe direction towards the exit.

FIGS. 200A, 200B show an embodiment of a mechanical type pump comprisingmechanically acting members in the form of rollers 180, 181 for emptyingthe reservoir 140. The rollers 180, 181 are arranged on opposite sidesof the reservoir 140 and have a length spanning the entire width of thereservoir 140, i.e. 10 cm or more. The rollers are each guided by twotracks 182 a, 183 a and 182 b, 183 b, respectively, and are driven by amotor integrated in the rollers (not shown) which preferably comprises aservo drive. The servo drive reduces the force required to move therollers 180, 181, so that a relatively small motor can be used inexchange for a longer emptying process. The tracks 182 a, 183 a, 182 b,183 b are arranged in pairs on opposite sides of the reservoir 140. Ascan be seen from FIG. 4B, the tracks have bent end portions 184 a, 184 bdirected away from the reservoir 140 so that the rollers 180, 181 canassume an inactive position in which they do not constrict the reservoir140. When emptying of the reservoir is desired, the rollers 180, 181 aredriven along the tracks in the direction of the arrows, therebyapproaching each other and constricting the reservoir 140. When therollers are further guided by the tracks along the length of thereservoir in their proximate position, they mechanically squeezeintestinal contents in the direction towards and out of the exit of thereservoir 140. When the rollers 180, 181 have reached their finalposition and the reservoir 140 is emptied, they are returned to theirinitial inactive position at the end portions 184 a, 184 b of thetracks. Instead of rollers on each side of the reservoir 140, it can besufficient to provide one or more rollers only on one side of thereservoir 140 and place a counteracting plate on the respective oppositeside of the reservoir 140.

Again, emptying of the intestinal reservoir 140 can be activated by thepatient pressing the manually operable actuator 99 subcutaneouslyimplanted in the patient's abdominal wall 101, the actuator 99 beingconnected to the combined energy storage means and controller device150. Energy is supplied from the device 150 to the motor or motorsinside the rollers 180, 181.

FIGS. 201A, 201B show an embodiment of a hydraulic type pump comprisinga hydraulically acting member 190 adapted to act on the intestinal wallof the reservoir 140 from the outside thereof. The hydraulically actingmember 190 is connected to an artificial reservoir 193 supplying thehydraulically acting member 190 with hydraulic fluid. The artificialreservoir 193 is of a size sufficiently large to accommodate hydraulicfluid in an amount corresponding to the volume of the intestinalreservoir 140. The artificial reservoir 193 has a flexible wall to allowthe hydraulic fluid to be drawn off from and to be filled back into theartificial reservoir 193. The hydraulically acting member 190 is offlexible material and may be tube-like or bag-like so as to accommodatetherein the intestinal reservoir 140. As shown in FIG. 201B, thereservoir 140 is surrounded by the hydraulically acting member 190. Thehydraulically acting member 190 is divided into a plurality of chambers,wherein a first chamber 191 and a last chamber 194 are connected to theartificial reservoir 193 by hydraulic conduits. The chambers areinterconnected via connections 192, which may be simple holes acting asa throttle or may include one or more valves that are preferablyautomatically controlled.

Upon activation of the system by the patient using the subcutaneousactuator 99, emptying of the intestinal reservoir 140 is started bysupplying hydraulic fluid from the artificial reservoir 193 to the firstchamber 191. The next following chambers are supplied with the hydraulicfluid through the connections 192, thereby causing the hydraulicallyacting member 190 to be filled slowly from the first chamber 191 to thelast chamber 194. The filling of the chambers occurs sequentially, withthe next following chamber starting to fill before the foregoing chamberis filled completely. In this manner, intestinal contents arehydraulically squeezed out in the direction towards the exit of thereservoir 140. When the hydraulically acting member 190 is completelyfilled with hydraulic fluid, the reservoir 140 is completelyconstricted. The hydraulic fluid is then withdrawn from the chambers ofthe hydraulically acting member 190 back into the artificial reservoir193 using negative pressure. The intestinal reservoir 140 may then startto fill up with intestinal contents again.

Again, this process is controlled by the device 150, which is connectedto the artificial reservoir 193. Connected to or integrally formed withthe artificial reservoir 193 is an electrically driven pump (not shown)for pumping the hydraulic fluid into and withdrawing the hydraulic fluidfrom the hydraulically acting member. The electrically driven pump issupplied with energy from the combined energy storage means and controldevice 150.

In another embodiment, each chamber of the hydraulically acting member190 may have separate fluid connection to the artificial reservoir 193in order to be able to be filled individually. The intestinal reservoir140 may be emptied by consecutively filling two adjacent chambers of thehydraulically acting member 190, i.e. first filling the first and secondchamber, then emptying the first chamber while filling the thirdchamber, then emptying the second chamber while filling the fourthchamber, and so forth. In this manner intestinal contents are squeezedtowards and out of the exit of the intestinal reservoir 140.

Alternatively, instead of applying a negative pressure for evacuatingthe chambers, at least one valve, preferably two valves, may be provided(not shown) between the hydraulically acting member 190 and theartificial reservoir 193 which, when in an appropriate operationalposition, allows the hydraulic fluid to passively flow from thehydraulically acting member back into the artificial reservoir 193 whenthe intestinal reservoir 140 fills with intestinal contents and which,when in an appropriate other position, prevents the hydraulic fluid toflow from the hydraulically acting member back into the artificialreservoir when the intestinal reservoir is being emptied.

As in all embodiments, emptying of the reservoir 140 is coordinated withthe opening and closing of the entry valve 194 and exit valves 61, 62,63.

Energy Transmission

An energy source may be provided for supplying energy directly orindirectly to at least one energy consuming part of the system, inparticular for driving the pump or the motor of the pump. Preferably,the energy source includes a battery or an accumulator, such as one ormore of a rechargeable battery and a capacitor, as an energy storagemeans. The energy storage means is advantageously adapted for beingimplanted inside the patient's body, as in the case of the aforementioned combined energy storage means and control device 150.

Energy is preferably transmitted wirelessly. Thus, where the energysource is provided for supplying energy directly or indirectly to atleast one energy consuming part of the system, the energy source maycomprise a wireless energy transmitter adapted to wirelessly transmitenergy from outside the patient's body to the at least one energyconsuming part. Alternatively, where the energy source includes abattery or an accumulator, in particular one which is implanted in thepatient's body, the energy source may comprise a wireless energytransmitter adapted to wirelessly transmit energy from outside thepatient's body to the energy storage means.

Where energy is not transmitted wirelessly, galvanic coupling elementsmay be provided at least between the accumulator and the energyconsuming part, in particular the motor, for transmitting energy to themotor in contacting fashion.

Preferably, in order to reduce the number of parts and possibly increasethe system's efficiency, the energy consuming part, in particular themotor, can be adapted to directly transform the wirelessly transmittedenergy from the accumulator into kinetic energy. In the alternative, theenergy consuming part will have to comprise a transforming device fortransforming the wirelessly transmitted energy from the accumulator intoelectric energy.

Similarly, the system preferably comprises an implantable energytransforming device for transforming the wirelessly transmitted energyfrom outside the patient's body into energy to be stored in theaccumulator of the implanted system and further comprises a wirelessenergy transmitter adapted to wirelessly transmit energy from outsidethe patient's body to said implantable energy transforming device.

It is further preferred to set up the system such that the energyconsuming part is driven with the electric energy, as said energytransforming device transforms the wireless energy into the electricenergy.

The energy transmitter can be adapted to generate an electromagneticfield, a magnetic field or an electrical field. The wireless energy maybe transmitted by the energy transmission device by at least onewireless signal. More specifically, the energy transmitter may beadapted to transmit the energy by at least one wireless energy signal,which may comprise an electromagnetic wave signal, including at leastone of an infrared light signal, a visible light signal, an ultra violetlight signal, a laser signal, a microwave signal, an X-ray radiationsignal, and a gamma radiation signal. Also, the wireless energy signalmay comprise a sound or ultrasound wave signal. Furthermore, thewireless energy signal may comprise a digital or analog signal or acombination thereof.

Primary Energy Source

A primary energy source may be provided for charging the energy storagemeans with energy from outside the patient's body. The primary energysource is preferably adapted to being mounted on the patient's body.

Energy Transmission Feedback

A feedback subsystem, which can make part of a control device describedsubsequently, can advantageously be provided to wirelessly send feedbackinformation related to the energy to be stored in the energy storagemeans from inside the human body to the outside thereof. The feedbackinformation is then used for adjusting the amount of wireless energytransmitted by the energy transmitter. Such feedback information mayrelate to an energy balance which is defined as the balance between anamount of wireless energy received inside the human body and an amountof energy consumed by the at least one energy consuming part.Alternatively, the feedback information may relate to an energy balancewhich is defined as the balance between a rate of wireless energyreceived inside the human body and a rate of energy consumed by anenergy consuming part.

Control Unit

It is advantageous to provide a control unit adapted to directly orindirectly control one or more elements of the system, such as forcontrolling opening of the exit valve and/or closing of the entry valvein combination with the pump, in particular in a manner such that whenone of the two valves is closed, the respective other valve is open, andvice versa.

At least part of the control unit may be adapted to be implantable inthe patient's body. For instance, as described before, a manuallyoperable actuator 99 in the form of a switch may be provided foractivating the control unit, the switch preferably being arranged forsubcutaneous implantation so as to be operable from outside thepatient's body. Alternatively, the control unit may comprise a firstpart adapted for implantation in the patient's body and a second partadapted to cooperate with the first part from outside the patient'sbody. In this case, the control unit can be adapted to transmit datafrom the external second part of the control unit to the implanted firstpart of the control unit in the same manner as energy is transmitted bysaid wireless energy transmitter from outside the patient's body to saidimplantable energy transforming device.

That is, the second part of the control unit may be adapted towirelessly transmit a control signal to the implantable first part ofthe control unit for controlling the at least one energy consuming partfrom outside the patient's body. Also, the implantable first part of thecontrol unit may be programmable via the second part of the controlunit. Furthermore, the implantable first part of the control unit may beadapted to transmit a feedback signal to the second part of the controlunit.

Sensor

Furthermore, a physical parameter sensor adapted to directly orindirectly sense a physical parameter of the patient can be provided.The physical parameter sensor may be adapted to sense at least one ofthe following physical parameters of the patient: a pressure within theartificial intestine section, a pressure within the patient's naturalintestine, an expansion of the artificial intestine section, adistension of an intestinal wall of the patient's natural intestine, amovement of the patient's intestinal wall.

Similarly, a functional parameter sensor adapted to directly orindirectly sense a functional parameter of the system can be provided,wherein the functional parameter sensor may be adapted to sense at leastone of the following functional parameters of the system: a pressureagainst a part of the system such as the artificial intestine section, adistension of a part of the system such as a wall of the artificialintestine section, an electrical parameter such as voltage, current orenergy balance, a position or movement of a movable part of the system.

Preferably, an indicator is coupled to the sensor or sensors, theindicator being adapted to provide a signal when a sensor senses a valuefor the parameter beyond a predetermined threshold value. The sensorsignal may comprise at least one of the following types of signals: asound signal, a visual signal.

Through-Flow Arrangement of Reservoir

The intestinal reservoir has an upstream part with a first intestinalopening and a downstream part with a second intestinal opening.

The system may include a first intestinal passageway in flowcommunication with the first intestinal opening arranged fortransferring intestinal contents to the reservoir and/or the system maycomprise a second intestinal passageway in flow communication with thesecond intestinal opening, said second intestinal passageway beingarranged for transferring intestinal contents from the reservoir. Thesecond intestinal passageway may be surgically connected to a surgicallycreated stoma, in which case the pump is adapted to pump intestinalcontents from the reservoir out through said stoma. For instance, thedownstream part of the second intestinal passageway may be advancedthrough the abdominal wall and skin, thereby achieving an intestinalstoma Alternatively, the second intestinal passageway may be surgicallyconnected to the patient's anus or to tissue adjacent the patient'sanus, in which case the pump is adapted to pump the intestinal contentsout through the patient's anus.

The reservoir may be made of the small intestine or the reservoir may bemade of the large intestine. Accordingly, the second intestinalpassageway may be made of the small intestine or the large intestine.

In yet another embodiment, the second intestinal passageway may also besurgically connected to an artificial intestinal piece, wherein saidartificial intestinal piece may comprise a valve for controlling theflow of intestinal contents. The artificial intestinal piece may beadapted to be connected to the patient's small intestine or to thepatient's large intestine or to the patient's anus or to tissue adjacentthe patient's anus or to a surgically created stoma.

Method of Treatment (Implantation)

The invention does not only relate to the system described above, butalso to a method of implanting the system or at least components thereofwithin the patients body.

As mentioned before, the reservoir of the system is made from thepatient's intestine. A respective surgical method of treating thepatient therefore comprises the steps of:

-   -   cutting the patient's skin and abdominal wall,    -   dissecting an area of the patient's intestine,    -   cutting the patient's intestine along a mutual contact line of        laterally adjacent sections of a bent portion thereof and        connecting by suturing and/or stapling the resulting upper and        lower halves of the intestine so as to form an intestinal wall        of a reservoir,    -   implanting at least a pump as part of a flow control device so        as to permanently reside inside the patient's body and to act on        said intestinal wall so as to reduce the reservoir's volume in        order to empty intestinal contents from the reservoir to outside        the patient's body, and    -   thereafter, permanently closing the abdominal wall and skin.

A respective laparoscopic surgical method of treating the patientcomprises the steps of:

-   -   making a small opening in the patient's skin and abdominal wall,    -   introducing a needle in the abdominal cavity,    -   inflating the abdominal cavity with gas,    -   inserting at least one trocar into the cavity,    -   introducing a camera through the trocar,    -   inserting at least one dissecting instrument preferably through        a second trocar.    -   dissecting an area of the intestine,    -   cutting the patient's intestine along a mutual contact line of        laterally adjacent sections of a bent portion thereof and        connecting by suturing and/or stapling the resulting upper and        lower halves of the intestine so as to form an intestinal wall        of a reservoir,    -   implanting at least a pump as part of a flow control device so        as to permanently reside inside the patient's body and to act on        said intestinal wall so as to reduce the reservoir's volume in        order to empty intestinal contents from the reservoir to outside        the patient's body,    -   extracting the instruments, camera and trocar, and in relation        thereto    -   suturing, if necessary, the abdominal wall and permanently        closing the skin.

As also mentioned before, the system may be surgically connected to asurgically created stoma or to the patient's rectum or anus or to tissueadjacent the patient's anus. This would require, where a stoma isinvolved, the following additional steps:

-   -   cutting the patient's skin and abdominal wall so as to create an        opening for an intestinal stoma,    -   dissecting the area of the opening,    -   dividing the intestine downstream of the reservoir so as to        maintain an upstream natural intestine section still connected        to the reservoir with a cross-sectional opening at the        downstream end thereof,    -   dissecting the mesentery of the upstream natural intestine        section in the area of the cross-sectional opening at the        downstream end thereof to prepare for creating the intestinal        stoma,    -   advancing the upstream natural intestine section through the        abdominal wall and skin and    -   suturing the upstream natural intestine section in the area of        the cross-sectional opening to the skin with the intestinal        mucosa turned inside out, thereby achieving the intestinal        stoma.

Where the system may be surgically connected to a the patient's anus orto tissue adjacent the patient's anus, this would require the followingadditional steps:

-   -   dividing the intestine so as to create an upstream natural        intestine section having a cross-sectional opening at the        downstream end thereof and a downstream natural intestine        section leading to the patient's anus,    -   dissecting the area of the patient's anus and surgically        separating the downstream natural intestine section from the        patient's anus, whereas the steps of dividing the intestine and        separating the intestine section leading to the patient's anus        can alternatively be carried out in reversed order,    -   dissecting the mesentery of the upstream natural intestine        section in the area of the cross-sectional opening at the        downstream end thereof to prepare for connecting the upstream        natural intestine section to the patient's anus or tissue        adjacent the patient's anus,    -   advancing the downstream end of the upstream natural intestine        section through the patient's anus, and    -   suturing the cross-sectional opening of the upstream natural        intestine section to the patient's anus or tissue adjacent the        patient's anus.

In context with the implantation of an electrical stimulation type pumpdescribed previously, the method may further involve the step ofimplanting at least one holding device with electrodes in the vicinityof the intestinal reservoir so as to allow for at least partialcontraction of the intestinal reservoir by means of electricalstimulation of muscle or neural tissue with the aid of the electrodes ofthe holding device. Preferably, electric pulses are applied to theintestine section by means of the stimulation device.

According to a preferred embodiment, as also mentioned before, folds aresurgically created from the intestinal wall of the reservoir andcomponents of the electrical stimulation type pump are implanted in thefolds. The open side of the folds is preferably closed by sewing,bonding and/or stapling the tissue of the intestinal wall together so asto form bags in which the holding devices of the pump are placed eitherafter or preferably before the closing of the folds. While the holdingdevices are preferably longitudinal, they may likewise have any othershape, whereby the folds or bags are surgically formed from theintestinal wall so as to accommodate therein the individual stimulationdevices.

Preferably, a plurality of holding devices is implanted side by sidealong the intestinal wall of the reservoir so as to be able to stimulatedifferent portions of the intestinal wall over time. More specifically,the stimulation devices may be implanted to pump intestinal contentsalong the intestinal reservoir by, over time, stimulating the differentportions of the intestinal wall consecutively or, preferably, in a wavelike manner.

Alternatively, or in addition to the electrical stimulation type pump, aconstriction type pump, such as a mechanical pump or a hydraulic pump,may be implanted so as to allow for at least partial mechanical orhydraulic constriction of the intestinal reservoir by means of theconstriction type pump. The constriction type pump may advantageously becombined with the electrical stimulation type pump so as to allow foradding further constriction of the intestinal reservoir by stimulatingsections of the intestinal reservoir with electric pulses. Inparticular, this may be used for pumping intestinal contents along theintestinal reservoir by, over time, stimulating the different portionsof the intestine section in a wave-like manner, when constriction of theintestine section caused by the constriction device is released.

Exit and Entry Valve

Where an exit valve is provided in addition to the at least one pump forpreventing intestinal contents to exit the intestinal reservoirunintentionally, the method of implantation preferably comprises theadditional step of placing the exit valve outside and adjacent to asection of the intestine downstream of the intestinal reservoir so as toallow acting on said intestine section from the outside thereof by meansof the exit valve.

Similarly, where an entry valve is provided for preventing backflow ofintestinal contents from the reservoir when the intestinal reservoir isbeing emptied, the method of implantation may further comprise theadditional step of placing the entry valve outside and adjacent to asection of the intestine upstream of the intestinal reservoir so as toallow acting on said intestine section from the outside thereof by meansof the entry valve.

It should be noted that any embodiment or part of embodiment or featureor method or part of method or system or part of system may be combinedin any possible way and that method and apparatus features may beinterchanged.

Sleeve

FIG. 202 schematically shows a body 100 of a patient with a first tissueconnector 1 connected to the end of the patient's large bowel 50 and asecond tissue connector 1 a interconnecting two pieces of the patient'saorta 60. The tissue connector 1 may either connect the large bowel 50to the patient's anus or to an artificial anus which may include anexcrements collecting container. The tissue connector 1 a may includebetween its two ends a heart valve, a blood pump, a drug delivery deviceor the like.

The tissue connectors 1 and 1 a shown in FIG. 202 represent only a fewof many different possible locations and applications of the tissueconnector within the human's or, alternatively, an animal's body.Further examples of possible applications have already been outlinedfurther above.

FIGS. 203a and 203b show a first embodiment of the tissue connector 1 inthe state of mounting the tissue connector to a tubular part of livingtissue 70. The tissue connector 1 comprises a conduit 2 with a first end3 and a second end 4. In FIG. 203a , the first end 3 of the conduit 2has already been inserted into an end portion of living tissue 70. Theinner cross section of the conduit 2 is selected to approximately matchthe inner cross section of the tubular living tissue 70 so as not toobstruct any flow of material. The thickness of the wall 5 of theconduit, which is typically circular, is chosen to provide sufficientstrength so that it does not collapse under the forces that will actupon the conduit during use, while providing sufficient flexibilitywhere needed. On the other hand, the thickness should not be chosen toolarge since the living tissue will have to be stretched over the outersurface 6 of the conduit 2 without damage and without excessivelyaffecting blood circulation within the end portion 71 of the livingtissue 70.

The wall 5 of conduit 2 is tapered towards its leading edge 7. Inaddition, the leading edge 7 is rounded. These two measures preventdamage to the living tissue 70 when the conduit 2 is inserted into theend portion 71 of the living tissue 70.

The second end 4 may serve and be adapted to be connected to animplantable medical device, an implantable reservoir, an implantablepump, an implantable motor or a combination of the afore mentioned items(generally designated with 200). It may also be connected to any otherimplantable device 200. The implantable device 200 may even form a partof the tissue connector 1, either integrally or attached thereto.

The implantable device 200 may also be a medical device replacing one ormore of the patient's organs, such as an artificial urine bladder, afecal excrement's collecting container, an artificial urethra, anartificial heart, an artificial esophagus, an artificial trachea or thelike. Alternatively, the second end 4 of the conduit 2 may be connectedto a biological implant obtained from a third party's body, such as aurine bladder, an intestine, a urethra, a ureter, a kidney, a bowel, aheart, an esophagus, a trachea, a blood vessel or the like.

The device 200 may also comprise a flow restrictor for partial orcomplete restriction of flow through the conduit. This can be suitablee.g. in the case where the tissue connector is located at the end of thepatient's large bowel.

The device 200 may also be placed between the tissue connector 1 and asecond tissue connector 1 b with conduit 2 b, as is indicated in FIG.203a by dotted lines. This arrangement is practical where the device 200has to be placed at a location within one of the patient's organs, suchas in a blood vessel, in which case the blood vessel would be dividedand the device 200 placed between the two tissue connectors 1 and 1 bconnected to the respective free ends of the divided blood vessel. As anexample, the device 200 could include a flow restrictor, such as anartificial heart valve, or a drug delivery reservoir.

Apart from the conduit 2 and the optional device 200, the tissueconnector 1 of the embodiment shown in FIG. 203a has a flexible sleeve10 axially extending and closely fitted around a part of the outersurface 6 of the conduit 2. The flexible sleeve 10 may be deliveredseparately from the conduit 2 and placed over the conduit's outersurface 6 shortly before implantation into the patient's body. However,it is preferred to provide the conduit 2 with the flexible sleeve 10 asa unitary item, the flexible sleeve 10 preferably fixed to the outersurface 6 by means of bonding, welding and/or clamping. In the case ofbonding, it can be advisable to pretreat the outer surface 6 e.g. with aprimer, depending upon the material combination to be bonded together.

In FIG. 203a , the flexible sleeve 10 is rolled upon itself and can beunrolled over the portion 71 of living tissue 70 so as to cover, sealand protect that portion 71 on the first end 3 of the conduit 2, as isshown in FIG. 203b . The tissue portion 71 and the overlapping part 11of flexible sleeve 10 are fixed to the first end 3 of the conduit 2 bysuturing threads 20 therethrough and through the wall 5 of the conduit2, as is indicated in FIG. 203b by dotted lines.

The flexible sleeve 10 is a multilayer material comprising a porousingrowth layer to allow ingrowth of living tissue. For that, it has anetlike structure. On top of the ingrowth layer 11 there is provided asupport layer 12. The support layer 12 may have one or more of variousfunctions. One possible function is to provide support to the ingrowthlayer 11 so as to ease handling and/or prevent fussing of the ingrowthlayer. Also, the support layer 12 may provide some tension, therebyexerting a compressive force in a radial direction so as to slightlyclamp the tissue portion 71 against the outer surface 6 of the conduit2. For that, the support layer should have an appropriate elasticity.Finally, the support layer may provide protection for the tissue portion71.

Preferably, the support layer should be porous so that exchange betweenthe tissue portion 71 and the surrounding area within the patient's bodyis possible. This is an important aspect for the ingrowth of livingtissue material into the ingrowth layer 11. Expandedpolytetrafluoroethylene (ePTFE) is particularly suitable, as it isflexible, inert and can be made with any desired porosity. Otherbiocompatible polymers, such as polyurethane and the like, are suitableas well.

FIGS. 204a and 204b show an alternative of the first embodiment of thetissue connector which differs from the connector shown in FIGS. 203aand 203b solely by the fact that the flexible sleeve 10 is not rolledupon itself but, instead, folded upon itself. By unfolding the foldedsleeve 10, it can be placed over the tissue portion 71 in the samemanner as discussed above in relation to FIGS. 203a, 203b , as is shownin FIG. 204 b.

FIGS. 205 and 206 show a second embodiment of a tissue connector wherethe flexible sleeve 10 is arranged such that it is foldable upon itself.More particularly, the first end 3 of the conduit 2 is inserted in thetissue portion 71 of living tissue 70 to an extent that it overlaps afirst portion 13 of the flexible sleeve 10. The remaining portion 14 ofthe flexible sleeve 10 not being covered by the tissue portion 71 isrolled upon itself and can be unrolled so as to cover the tissue portion71. As a result shown in FIG. 206b , the flexible sleeve 10 is foldedupon itself with the tissue portion 71 placed intermediate the foldedsleeve 10.

Different to the embodiments described before, suturing the tissueportion 71 to the wall 5 of the conduit 2 is carried out before thetissue portion 71 is covered with the remaining part 14 of the flexiblesleeve 10. The remaining part 14 thereby seals any penetration holescaused by the suturing.

In an alternative of the second embodiment, not shown, the first end 3of the conduit 2 will be inserted in the tissue portion 71 only so farthat the tissue portion 71 does not overlap with the flexible sleeve 10.Thus, after unrolling the flexible sleeve 10, only a part of the foldedsleeve 10 will cover the tissue portion 71.

Furthermore, also not shown, the remaining part 14 of the sleeve 10 isnot necessarily rolled upon itself, as shown in FIG. 205, but may layflat against the outer surface 6 of the conduit 2, similar to theembodiment shown in FIG. 204 a.

As will be recognized, the portion 13 of the flexible sleeve 10 isarranged in a circumferential groove provided in the outer surface 6 ofthe conduit 2. It is advantageous when the depth of the groovecorresponds to the thickness of the flexible sleeve 10. This willfacilitate introducing the first end 3 of the conduit 2 into the livingtissue 70.

FIG. 207 shows a possibility of fixing the conduit 2, such as theconduit's second end 4, to a tubular part of living tissue 80 or to ahose that belongs or leads to a medical device, reservoir, or the like.Accordingly, at least one bulge 15 extends outwardly from the conduit'souter surface 6 in a circumferential direction of the conduit 2 about atleast a part of the conduit's circumference. Furthermore, at least oneblocking ring 30 loosely fitting over the outer surface 6 of the conduit2 with a clearance between the outer surface 6 and the blocking ring 30is provided for mounting the tubular living tissue 80 (or alternativelythe hose) within the clearance. The blocking ring has an innercross-sectional diameter which is about the same as the outercross-sectional diameter of the bulge 15. This prevents the blockingring from slipping over the bulge when the living tissue 80, as shown inFIG. 207, is mounted within the clearance.

When an axial force tends to pull the tubular living tissue 80 from theouter surface 6 of the conduit 2, the blocking ring 30 will move withthe tubular tissue 80, thereby compressing the tubular tissue 80 againstthe bulge 15, so as to prevent any further slippage of the tubulartissue 80 over the bulge 15. This is a self-enhancing effect.

This kind of locking mechanism can be combined with any of theaforementioned embodiments of the tissue connector. Of these variants,only one shall examplary be described in the following in relation toFIGS. 208a and 208b . The embodiment shown in FIGS. 208a and 208bsubstantially correspond to the embodiment of FIGS. 203a and 203b ,where the flexible sleeve 10 is rolled upon itself and then unrolled tocover the tubular tissue 80 which, in this case, is pulled over thesecond end 4 of the conduit 2 sufficiently far so as to extend also overthe bulge 15. After the flexible sleeve 10 has been unrolled over thetubular tissue 80, the blocking ring 30 is pushed over the flexiblesleeve against the bulge 15. After a while, the threads 20 sutured tothe tubular tissue 80 and the wall 5 of the conduit 2 (FIG. 6a ) willhave been absorbed by the patient's body and, about during the sametime, living tissue will have formed in and connect the tubular tissue80 to the ingrowth layer 11 of the flexible sleeve 10. Therefore, as thetubular tissue 80 tends to be pulled off of the second end 4 of theconduit 2, the blocking ring 30 will also be moved, press the tubulartissue 80 and the flexible sleeve 10 against the bulge 15 and therebyprohibit any further slippage of the tubular tissue 80 over the bulge15. The friction coefficient between the blocking ring 30 and the outersurface of the flexible sleeve should be higher than the frictioncoefficient which the conduit's outer surface 6 has in relation to thetubular tissue 80.

Note that the flexible sleeve 10 in its unrolled state as shown in FIG.6b must not necessarily extend over the bulge 15 but can end a distanceaway from the bulge. In that situation, the blocking ring 30 would notclamp the sleeve 10 against the bulge 15.

The afore mentioned embodiments have mainly been described in relationto a tissue connector of which only one of the two ends is intended tobe connected to tubular living tissue. However, as has also beenmentioned before, there are various applications where the tissueconnector may connect two pieces of tubular living tissue, such as whenbridging two pieces of identical tubular living tissue or connectingtubular living tissue with tissue of a biological transplant. For that,the second end 4 of the tissue connector's conduit 2 can be designedaccording to any of the aforementioned embodiments. FIG. 209 gives justan example of how such tissue connector could be designed. Accordingly,two flexible sleeves 10 are integrally formed to form a single flexiblesleeve 10 a, with each of the sleeves 10 being rolled upon itself,similar to the embodiment shown in FIG. 2a . The two flexible sleeves 10can, of course, be provided separately. Furthermore, a bulge 15 and ablocking ring 30 can be provided at one or both of the conduit's ends 3and 4. Also, a medical device, flow restrictor or the like can beincorporated intermediate the two ends 3 and 4.

Bulge

FIG. 210 schematically shows a body 100 of a patient with a first tissueconnector 1 connected to the end of the patient's large bowel 50 and asecond tissue connector 1 a interconnecting two pieces of the patient'saorta 60. The tissue connector 1 may either connect the large bowel 50to the patient's anus or to an artificial anus which may include anexcrements collecting container. The tissue connector 1 a may includebetween its two ends a heart valve, a blood pump, a drug delivery deviceor the like.

The tissue connectors 1 and 1 a shown in FIG. 201 represent only a fewof many different possible locations and applications of the tissueconnector within the human's or, alternatively, an animal's body.Further examples of possible applications have already been outlinedfurther above.

FIG. 211 shows a first embodiment of the tissue connector 1 connected toa tubular part of living tissue 80. The tissue connector 1 comprises aconduit 2 with a first end 3 and a second end 4. The second end 4 of theconduit 2 has already been inserted into an end portion of living tissue80. The inner cross section of the conduit 2 is selected toapproximately match the inner cross section of the tubular living tissue80 so as not to obstruct any flow of material. The thickness of the wall5 of the conduit, which is typically circular, is chosen to providesufficient strength so that it does not collapse under the forces thatwill act upon the conduit during use, while providing sufficientflexibility where needed. On the other hand, the thickness should not bechosen too large since the living tissue will have to be stretched overthe outer surface 6 of the conduit 2 without damage and withoutexcessively affecting blood circulation within the end portion 81 of theliving tissue 80.

The wall 5 of conduit 2 is tapered towards its leading edge 7. Inaddition, the leading edge 7 is rounded. These two measures preventdamage to the living tissue 80 when the conduit 2 is inserted into theend portion 81 of the living tissue 80.

The first end 3 may serve and be adapted to be connected to animplantable medical device, an implantable reservoir, an implantablepump, an implantable motor or a combination of the afore mentioned items(generally designated with 200). It may also be connected to any otherimplantable device 200. The implantable device 200 may even form a partof the tissue connector 1, either integrally or attached thereto.

The implantable device 200 may also be a medical device replacing one ormore of the patient's organs, such as an artificial urine bladder, afecal excrement's collecting container, an artificial urethra, anartificial heart, an artificial esophagus, an artificial trachea or thelike. Alternatively, the first end 3 of the conduit 2 may be connectedto a biological implant obtained from a third party's body, such as aurine bladder, an intestine, a urethra, a ureter, a kidney, a bowel, aheart, an esophagus, a trachea, a blood vessel or the like.

The device 200 may also comprise a flow restrictor for partial orcomplete restriction of flow through the conduit. This can be suitablee.g. in the case where the tissue connector is located at the end of thepatient's large bowel.

The device 200 may also be placed between the tissue connector 1 and asecond tissue connector 1 b with conduit 2 b, as is indicated in FIG.211 by dotted lines. This arrangement is practical where the device 200has to be placed at a location within one of the patient's organs, suchas in a blood vessel, in which case the blood vessel would be dividedand the device 200 placed between the two tissue connectors 1 and 1 bconnected to the respective free ends of the divided blood vessel. As anexample, the device 200 could include a flow restrictor, such as anartificial heart valve, or a drug delivery reservoir.

Apart from the conduit 2 and the optional device 200, the tissueconnector 1 of the embodiment shown in FIG. 211 has a bulge 15 thatextends outwardly from the conduit's outer surface 6 in acircumferential direction of the conduit 2 about at least a part of theconduit's circumference. Furthermore, at least one blocking ring 30loosely fitting over the outer surface 6 of the conduit 2 with aclearance between the outer surface 6 and the blocking ring 30 isprovided for mounting the tubular living tissue 80 within the clearance.The blocking ring has an inner cross-sectional diameter which is aboutthe same as the outer cross-sectional diameter of the bulge 15. Thisprevents the blocking ring from slipping over the bulge when the livingtissue 80, as shown in FIG. 211, is mounted within the clearance.

When an axial force tends to pull the tubular living tissue 80 from theouter surface 6 of the conduit 2, the blocking ring 30 will move withthe tubular tissue 80, thereby compressing the tubular tissue 80 againstthe bulge 15, so as to prevent any further slippage of the tubulartissue 80 over the bulge 15. This is a self-enhancing effect.Preferably, the blocking ring in this and in the subsequently describedembodiments is made from a material that has a friction coefficient inrelation to living human (outer) mucosa tissue that is higher than afriction coefficient which the conduit's outer surface has in relationto living human (inner) serosa tissue.

FIG. 212 shows a second embodiment of the tissue connector 1 comprisingthe conduit 2 with each of its first and second ends 3 and 4 having acircumferential bulge 15. Between the two bulges 15 two blocking rings30 are arranged. Tubular living tissue 80 has been pulled over theconduit 2 and through the blocking rings 30, and the blocking rings 30have then been pushed into a position closest to the bulges 15.Therefore, when stretching forces are applied to the tubular tissue 80in the one or the other direction, depending upon the direction one ofthe two blocking rings 30 will move towards the associated bulge 15,thereby clamping the tissue 80 between the blocking ring 30 and thebulge 15 and prohibiting any further slippage of the tissue 80 off theconduit 2.

The embodiment shown in FIG. 212 is particularly suitable to strengthenweak sections in a tubular part of living tissue or to seal a poroussection, such as a porous section of the patient's intestine.

The same tissue connector as shown in FIG. 212 may also be used toconnect two separate ends of tubular tissue or to connect one end oftubular tissue with another end of a hose or the like that may lead e.g.to an implantable medical device or to an exit port, such as anartificial body exit.

FIG. 213 shows a third embodiment that can be used as an alternative tothe embodiment previously discussed in relation to FIG. 212. Again, theconduit 2 has two bulges 15 to prevent the tubular tissue 80 fromslipping off of the conduit. However, in this embodiment the bulges 15are arranged in close proximity to one another so that a single blockingring 30 located between the two bulges 15 in an axial direction of theconduit will be sufficient to cooperate with one or the other of the twobulges 15 depending upon the direction of the stretching force actingupon the tissue 80.

FIGS. 214a and 214b show an alternative for mounting living tissue onthe free end 3 of the tissue connector 1 to either another part ofliving tissue 70 or to a hose. Apart from the conduit 2 and the bulge 15at the second end of the conduit 2, the tissue connector 1 of theembodiment shown in FIG. 5a has a flexible sleeve 10 axially extendingand closely fitted around a part of the outer surface 6 of the conduit2. The flexible sleeve 10 may be delivered separately from the conduit 2and placed over the conduit's outer surface 6 shortly beforeimplantation into the patient's body. However, it is preferred toprovide the conduit 2 with the flexible sleeve 10 as a unitary item, theflexible sleeve 10 preferably fixed to the outer surface 6 by means ofbonding, welding and/or clamping. In the case of bonding, it can beadvisable to pretreat the outer surface 6 e.g. with a primer, dependingupon the material combination to be bonded together.

In FIG. 214a , the flexible sleeve 10 is rolled upon itself and can beunrolled over the portion 71 of living tissue 70 so as to cover, sealand protect that portion 71 on the first end 3 of the conduit 2, as isshown in FIG. 214b . The tissue portion 71 and the overlapping part 11of flexible sleeve 10 are fixed to the first end 3 of the conduit 2 bysuturing threads 20 therethrough and through the wall 5 of the conduit2, as is indicated in FIG. 214b by dotted lines.

The flexible sleeve 10 is a multilayer material comprising a porousingrowth layer to allow ingrowth of living tissue. For that, it has anetlike structure. On top of the ingrowth layer 11 there is provided asupport layer 12. The support layer 12 may have one ore more of variousfunctions. One possible function is to provide support to the ingrowthlayer 11 so as to ease handling and/or prevent fussing of the ingrowthlayer. Also, the support layer 12 may provide some tension, therebyexerting a compressive force in a radial direction so as to slightlyclamp the tissue portion 71 against the outer surface 6 of the conduit2. For that, the support layer should have an appropriate elasticity.Finally, the support layer may provide protection for the tissue portion71.

Preferably, the support layer should be porous so that exchange betweenthe tissue portion 71 and the surrounding area within the patient's bodyis possible. This is an important aspect for the ingrowth of livingtissue material into the ingrowth layer 11. Expandedpolytetrafluoroethylene (ePTFE) is particularly suitable, as it isflexible, inert and can be made with any desired porosity. Otherbiocompatible polymers, such as polyurethane and the like, are suitableas well.

FIGS. 215a and 215b show an alternative which differs from the connectorshown in FIGS. 5a and 5b solely by the fact that the flexible sleeve 10is not rolled upon itself but, instead, folded upon itself. By unfoldingthe folded sleeve 10, it can be placed over the tissue portion 71 in thesame manner as discussed above in relation to FIGS. 214a, 214b , as isshown in FIG. 215 b.

FIGS. 216a and 216b show another alternative where the flexible sleeve10 is arranged such that it is foldable upon itself. More particularly,the first end 3 of the conduit 2 is inserted in the tissue portion 71 ofliving tissue 70 to an extent that it overlaps a first portion 13 of theflexible sleeve 10. The remaining portion 14 of the flexible sleeve 10not being covered by the tissue portion 71 is rolled upon itself and canbe unrolled so as to cover the tissue portion 71. As a result shown inFIG. 216b , the flexible sleeve 10 is folded upon itself with the tissueportion 71 placed intermediate the folded sleeve 10.

Different to the alternatives described before, suturing the tissueportion 71 to the wall 5 of the conduit 2 is carried out before thetissue portion 71 is covered with the remaining part 14 of the flexiblesleeve 10. The remaining part 14 thereby seals any penetration holescaused by the suturing.

In an even further alternative, not shown, the first end 3 of theconduit 2 will be inserted in the tissue portion 71 only so far that thetissue portion 71 does not overlap with the flexible sleeve 10. Thus,after unrolling the flexible sleeve 10, only a part of the folded sleeve10 will cover the tissue portion 71.

Furthermore, also not shown, the remaining part 14 of the sleeve 10 isnot necessarily rolled upon itself, as shown in FIG. 216a , but may layflat against the outer surface 6 of the conduit 2, similar to theembodiment shown in FIG. 215 a.

As will be recognized, the portion 13 of the flexible sleeve 10 isarranged in a circumferential groove provided in the outer surface 6 ofthe conduit 2. It is advantageous when the depth of the groovecorresponds to the thickness of the flexible sleeve 10. This willfacilitate introducing the first end 3 of the conduit 2 into the livingtissue 70.

Any of the described flexible sleeve connections can be combined withthe bulge locking ring locking mechanism. Of these variants, only oneshall exemplary be described in the following in relation to FIGS. 217aand 217b . The embodiment shown in FIGS. 217a and 217b substantiallycorrespond to the embodiment of FIGS. 216a and 216b , where the flexiblesleeve 10 is rolled upon itself and then unrolled to cover the tubulartissue 80 which, in this case, is pulled over the second end 4 of theconduit 2 sufficiently far so as to extend also over the bulge 15. Afterthe flexible sleeve 10 has been unrolled over the tubular tissue 80, theblocking ring 30 is pushed over the flexible sleeve against the bulge15. After a while, the threads 20 sutured to the tubular tissue 80 andthe wall 5 of the conduit 2 (FIG. 217a ) will have been absorbed by thepatient's body and, about during the same time, living tissue will haveformed in and connect the tubular tissue 80 to the ingrowth layer 11 ofthe flexible sleeve 10. Therefore, as the tubular tissue 80 tends to bepulled off of the second end 4 of the conduit 2, the blocking ring 30will also be moved, press the tubular tissue 80 and the flexible sleeve10 against the bulge 15 and thereby prohibit any further slippage of thetubular tissue 80 over the bulge 15. The friction coefficient betweenthe blocking ring 30 and the outer surface of the flexible sleeve shouldbe higher than the friction coefficient which the conduit's outersurface 6 has in relation to the tubular tissue 80.

Note that the flexible sleeve 10 in its unrolled state as shown in FIG.215b must not necessarily extend over the bulge 15 but can end adistance away from the bulge. In that situation, the blocking ring 30would not clamp the sleeve 10 against the bulge 15 but only the livingtissue 80.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiment,it is to be understood that the invention is not to be limited to thedisclosed embodiment, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the appended claims.

Aneurysm

In FIG. 218 a general view of a human 100 having a member, in particulara cuff 101, implanted for treating an aneurism is shown. In FIG. 218 thetreated aneurism is located on the aorta in the abdomen close to theY-bifurcation extending to the legs. The cuff 101 can be designed invarious ways but is generally formed as an implantable member adapted tobe placed in connection with a blood vessel having said vascularaneurysm, and adapted to exert a pressure on said aneurysm from theoutside of said blood vessel. In particular the pressure exerted on theblood vessel is essentially uniform from all direction and adapted tohinder the blood vessel to expand in all directions thereby acting toprevent the blood vessel from bursting. The pressure can in accordancewith one embodiment be essentially equal to or lower than the diastolicblood pressure of the treated patient. The cuff 101 can be made in anysuitable material such as an elastic material adapted for implantationin a human or mammal body.

The cuff 101 can exercise the pressure in a number of different ways. Inaccordance with one embodiment of the present invention the pressureapplied on the blood vessel can be mechanical and adjustable by means ofan adjustable screw or a similar means in order to apply a pressure onthe blood vessel. The cuff 101 can also be formed by a spring loadedmember and operated in a suitable manner such as hydraulically orpneumatically.

In FIG. 219 a cuff 101 in accordance with one embodiment of the presentinvention is shown in more detail. The cuff 101 comprises a number ofsegments 103 each adjustable and possible to tailor to fit a particularaneurism 102 of a blood vessel 104 to be treated. Each segment 103 canbe adjusted either as a whole or individually. The segments 103 can becontrolled and adjusted mechanically by an adjustable screw or similaror adapted to be filled with a fluid. For example, the segments can beprovided axially along the blood vessel and also radially along theblood vessel forming a matrix of sub-segments that constitutes the cuff101. In particular one segment can be located above and one below theaneurysm along the blood vessel.

The adjustment can be controlled by an electronic control unit 105adapted to receive and transmit signals from a transmitter/receiver 106located outside the body of a treated patient. The electronic controlunit can also comprise a chargeable battery 111 chargeable from theoutside by an external charger unit 112. The electronic control unit cancomprise an electrical pulse generator 109 for generating electricalpulses as is described in more detail below.

The electronic control unit 105, such as a microprocessor or a MCU or aFPGA or a ASIC and can further be connected to or comprise a hydraulicpump 110 associated with a reservoir 115 containing of a fluid used toregulate the pressure of the cuff 101. The pump is thus adapted to pumpthe hydraulic fluid in or out from the cuff 101 in order to adjust thepressure applied in the aneurism. The control mechanism used for keepingthe pressure in the cuff 101 can comprise a pressure tank 117.

In a preferred embodiment the pressure tank 117 is adapted to be able tochange its volume still keeping substantially the same pressure, thuskeeping the same pressure onto the aneurysm although some expansion ofsize of the aneurysm may occur. However, if the expansion goes too farthe pressure tank may come out of range to keep the pressure constantand with some kind of volume detection in the pressure tank the pump 110is then able to move fluid out from the pressure tank into the reservoir115 to again be within pressure range in the pressure tank. The pressuretank Is also able to even out the systolic pulses supplied to theaneurysmic wall

The cuff 101 can be shaped in any desirable form to enable treatment ofan aneurism wherever it is located. In accordance with one embodimentthe cuff 101 is provided with at least one sensor 107 adapted to sensethe pressure from the blood vessel that the cuff is surrounding.

The sensor(s) 107 used to generate a signal indicative of one or manyparameters related to the aneurism and the device 101 used for treatingthe aneurism can for example be a gauge sensor. The sensor 107 can beadapted to generate sensor signals used for monitoring parametersincluding but not limited to the pressure in a hydraulic cuff, thepressure of a mechanical cuff, the pressure of a pneumatic cuff, thepressure in a blood vessel, the shape of the blood vessel in particulara parameter related to the diameter of the aneurysm.

An alternative or complement to the remote placed transmitter 106 is aswitch (part of 105), preferable subcutaneously placed, such a switchmay be mechanical or electrical, such as a microprocessor or a MCU or aFPGA or a ASIC, or the switch may comprise a small hydraulic controlreservoir.

The restriction device may comprise any hydraulic device or mechanicaldevice or stimulation device alone or monitoring/sensor device in anycombination as described in the present application. The stimulationdevice may comprise both thermal stimulation or electrical stimulation.If a hydraulic system is used the hydraulic pump may in a systemcomprise an injection port (part of 110) for the injection of hydraulicfluid, preferable for calibration of hydraulic fluid. A subcutaneouslyplace switch may also be used as well as an feedback alarm systemconnected to the sensor/monitoring system.

Although the device has specific placements on the drawings it should beunderstood that the placement might vary.

Any combination of features or embodiments may comprise from any sourcewithin this application. Any embodiment in any combination that isdisclosed in this application, specially, but not limited to, in FIG.218-259, may be used.

In FIG. 220 a view illustrating a mechanical cuff 101 is shown. The cuffcan for example comprise an elastic material 301 kept in place by asuitable compressing device. The cuff 101 in accordance with oneembodiment of the present invention comprises an elastic material in theform of a number of gel filled pads 301. The pads 301 can be shaped in asuitable manner and in particular formed to absorb the geometrical shapeof the aneurysm. This can for example be achieved by providing pads withdifferent tilting angles. The elastic material 301 can be kept in placeby at least one adjustable fastening member 303. The fastening member303 can for example be adjusted by a screw 305 or a similar device. Byadjusting the fastening member 303 the pressure applied on the aneurysmcan be controlled.

In FIG. 221, a view Illustrating a mechanical cuff 101 is shown. Thecuff can for example comprise an elastic band 401. The band 401 can beadjusted by an adjustor 403 to provide a higher or smaller pressure onthe aneurysm.

In FIG. 222, a view illustrating a hydraulic cuff 101 is shown. The cuffcan for example comprise implantable member 501 adapted to hold fluid.The member 501 is adapted to be placed in connection with a blood vesselhaving an aneurysm. The member can exercise a pressure on the aneurysmthe blood vessel in response to the conditions of the fluid of themember 501. By filling the member with a fluid pressure can be appliedonto the aneurysm in order to prevent or reduce an expansion theaneurysm when implanted in a patient thereby enabling postoperativetreatment of the aneurysm. Further the treatment can be adjustedpostoperatively by regulating the pressure using an implanted pressureregulator 503. The pressure regulator can for example be formed by apressure tank 503 implanted in the patient interconnected via a hose 504with the member 501. The pressure tank can comprise an expandablereservoir 505 for storing superfluous fluid.

In FIG. 223, a view illustrating a hydraulic cuff 101 is shown. The cuffcan for example comprise implantable member 601 adapted to hold fluid.The member 601 is adapted to be placed in connection with a blood vesselhaving an aneurysm. The member can exercise a pressure on the aneurysmthe blood vessel in response to the conditions of the fluid of themember 601. By filling the member with a fluid pressure can be appliedonto the aneurysm in order to prevent or reduce an expansion theaneurysm when implanted in a patient thereby enabling postoperativetreatment of the aneurysm. Further the treatment can be adjustedpostoperatively by regulating the pressure using an implanted pressureregulator 603. The pressure regulator can for example be formed by aspring loaded tank 603 implanted in the patient interconnected via ahose 604 with the member 601. The spring 606 used to control thepressure of the tank and thereby indirectly the pressure applied by thecuff 101 on the aneurysm can be an adjustable spring in order to controlthe pressure.

In FIG. 224, a view illustrating a hydraulic cuff 101 is shown. The cuffcan for example comprise implantable member 701 adapted to hold fluid.The member 601 is adapted to be placed in connection with a blood vesselhaving an aneurysm. The member can exercise a pressure on the aneurysmthe blood vessel in response to the conditions of the fluid of themember 701. By filling the member with a fluid pressure can be appliedonto the aneurysm in order to prevent or reduce an expansion theaneurysm when implanted in a patient thereby enabling postoperativetreatment of the aneurysm. Further the treatment can be adjustedpostoperatively by regulating the pressure using an implanted pressureregulator 703. The pressure regulator can for example be formed by apump 703 implanted in the patient on a hose 704 interconnecting a tank705 with the member 701. The pump 703 is used to control the pressure ofthe member 703 by pumping fluid in and out of the member 701 and therebycontrolling the pressure applied by the cuff 101 on the aneurysm.

By sensing the pressure from the blood vessel the cuff can be controlledto apply a correct pressure on the blood vessel thereby keeping the formof the blood vessel essentially constant. For example the pressure mayvary over time as a result of changes in the wall of the blood vessel ofsurrounding tissue. Also the pressure will change as a function of thephase in which the heart is working. In other words the pressure will bedifferent in a systolic phase as compared to a diastolic phase. By usinga pressure sensor the pressure applied by the cuff 101 can be adapted toreact to changes in the sensed pressure and apply a correspondingcounter pressure. The sensor signals generated by the sensor(s) 107 ofthe cuff can also be used to trigger an alarm in response to the sensorsignal indicating an expansion of the aneurism. In response to an alarmsignal being generated the cuff can be automatically controlled toexercise a counter pressure on the blood vessel to counter or limit theexpansion of the aneurism.

In yet another embodiment, electrodes 108 can be provided in the cuff.The electrodes can be connected to the electrical pulse generator, whichis adapted to generate electrical pulses for stimulating the wall of theaneurism. The purpose of the electrical stimulation is to increase thetonus of the well of the aneurism.

In FIG. 225, a stimulation device 801 for treating a vascular aneurysmof a human or mammal patient is shown. The device 801 comprises at leastone implantable electrode 803 adapted to be placed in close connectionto the aneurysm. The electrode is adapted to provide an electricalstimulation pulse on a wall portion of the aneurysm. The electricalstimulation pulse can for example be generated by a pulse generator 805.The pulse generator can be implanted in the patient.

In accordance with one embodiment the electrical stimulation device usedfor treating a vascular aneurysm of a human or mammal patient isconnected to electrodes adapted to stimulate the well of the aneurism atmultiple stimulation points. The multiple stimulation groups may furtherbe organized in different stimulation groups which can stimulatedindependently of each other. In accordance with one embodiment theelectrical stimulation is performed with positive and or negativevoltage stimulation pulses. In one embodiment the current used forstimulation of the aneurysm wall is kept essentially constant.

The sequence of electrical pulses used to stimulation the wall of theaneurysm can be applied with a predetermined periodicity having periodsof no stimulation therein between during which periods withoutstimulation the wall of the aneurysm is allowed to rest. The electricalstimulation signal can also be Pulse Width Modulated to control theenergy applied. In accordance with one embodiment the electricalstimulation is applied during the systolic phase to increase the tonusof the wall of the aneurysm. The systolic phase can be detected by thesensors 107 used to sense the pressure of the aneurysm as describedabove.

In accordance with one embodiment the stimulation can be controlled tobe applied with a temporarily increased intensity and position duringemergency situations when the aneurysm is detected to rapidly expands,to limit the expansion of said aneurysm.

In order to provide input for controlling the pressure and or to monitorthe aneurysm a device 107 can be provided. In FIG. 226 a viewillustrating a sensor 901 used when treating or monitoring a vascularaneurysm of a human or mammal patient is shown. The sensor 901 is placedin relation to a wall portion of the aneurysm for generating a signalcorresponding to a parameter related to the aneurysm or the treatment ofthe aneurism. The signal generated by the sensor can be a signalcorresponding to the size of the aneurysm and is accessible via a signaloutput 903. For example the signal can be indicative of the diameter ofthe aneurysm. In accordance with one embodiment of the he sensor is agauge sensor. The sensor 901 can also be adapted to generate any outputrelated to monitoring or treatment of the aneurysm. For example thesensor can be adapted to sense the resistance, capacitance, pressure,volume extension, flexure of a member in contact with the aneurysm.

The shape of the cuff 101 can as stated above be tailor made to suit thelocation where an aneurysm is to be treated. In FIG. 227, a cuff 101 isseen from above in a direction aligned with a treated blood vessel. Ascan be seen in FIG. 220 each segment 3 can be sub-divided into a numberof sub segments 103 a, 103 b . . . together forming a closed loop aroundthe treated aneurysm. In case the aneurysm is located in the aortabifurcation region the cuff 101 can be Y-shaped as is shown in FIG. 228.

The device as described herein can be implanted in a patient using somesuitable surgical procedure as depicted in FIG. 229. For example, thedevice can be implanted by inserting a needle or a tube like instrumentinto the patient's abdominal cavity, step 1201. Next in a step 1203 apart of the patient's body with gas using the needle or tube likeinstrument thereby expanding said abdominal cavity. Next in a step 1205at least two laparoscopic trocars are placed in the cavity. Thereupon ina step 1207 a camera is inserted through one of the laparoscopic trocarsinto the cavity. Next in a step 1209 at least one dissecting tool isinserted through one of said at least two laparoscopic trocars. An areaof an aneurysm of a blood vessel is then dissected in a step 1211. Thedevice is then placed onto the aneurysmic blood vessel in a step 1213,and the pressure that the device exerts onto the aneurysm is adjusted ina step 1215.

In accordance with one embodiment of the present invention the devicecan be implanted by a procedure depicted in FIG. 230. First in a step1301 a needle or a tube like instrument is inserted into the patient'sthoraxial cavity. Next, in a step 1303 a part of the patient's body withgas using the needle or tube like instrument to fill and therebyexpanding the thoraxial cavity. Thereupon at least two laparoscopictrocars are placed in said cavity in a step 1305 Thereupon in a step1307 a camera is inserted through one of the laparoscopic trocars intothe cavity. Next in a step 1309 at least one dissecting tool is insertedthrough one of said at least two laparoscopic trocars. An area of ananeurysm of a blood vessel is then dissected in a step 1311. The deviceis then placed onto the aneurysmic blood vessel in a step 1313, and thepressure that the device exerts onto the aneurysm is adjusted in a step1315.

In accordance with one embodiment of the present invention the devicecan be implanted by a procedure depicted in FIG. 231. First in a step1401, the skin in the abdominal or thoraxial wall of the mammal patientis cut. Next, in a step 1403 an area of the aneurysm is dissected. Next,the device is then placed onto the aneurysmic blood vessel in a step1405, and the pressure that the device exerts onto the aneurysm isadjusted in a step 1407.

In accordance with one embodiment of the present invention the devicecan be implanted by a procedure depicted in FIG. 232. First in a step1501, the skin of the mammal patient is cut. Next, in a step 1503 anarea of the aneurysm is dissected. Next, the device is then placed ontothe aneurysmic blood vessel in a step 1505, and the pressure that thedevice exerts onto the aneurysm is adjusted in a step 1507.

FIG. 233 illustrates a system for treating a disease comprising a device10 of the present invention placed in the abdomen of a patient. Animplanted energy-transforming device 3020 is adapted to supply energyconsuming components of the device with energy via a power supply line3030. An external energy-transmission device 3040 for non-invasivelyenergizing the device 10 transmits energy by at least one wirelessenergy signal. The implanted energy-transforming device 10020 transformsenergy from the wireless energy signal into electric energy which issupplied via the power supply line 3030.

In one embodiment at least one battery may be a part of or replace theenergy transforming device 3020 to supply energy to the device 10 over apower supply line 3030. In one embodiment the battery is notrechargeable. In an alternative embodiment the battery is rechargeable.The battery supply may of course be placed both remote to andincorporated in the device.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 3040 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 3020 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 3040 into energy of a second form, whichtypically is different from the energy of the first form. The implanteddevice 10 is operable in response to the energy of the second form. Theenergy-transforming device 3020 may directly power the device with thesecond form energy, as the energy-transforming device 3020 transformsthe first form energy transmitted by the energy-transmission device 3040into the second form energy. The system may further include animplantable accumulator, wherein the second form energy is used at leastpartly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 3040 may be used to directly power thedevice, as the wireless energy is being transmitted by theenergy-transmission device 3040. Where the system comprises an operationdevice for operating the device, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the device.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 3020 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the device compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the device.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatients body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating thedevice. Alternatively, the energy-transmission device is controlled fromoutside the patient's body to release non-magnetic wireless energy, andthe released non-magnetic wireless energy is used for operating thedevice.

The external energy-transmission device 3040 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the device. Thecontrol signal is received by an implanted signal receiver which may beincorporated in the implanted energy-transforming device 3020 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 233 illustrates the system of FIG. 232 in the form of a moregeneralized block diagram showing the device 10, the energy-transformingdevice 3020 powering the device 10 via power supply line 3030, and theexternal energy-transmission device 3040, The patient's skin 3050,generally shown by a vertical line, separates the interior of thepatient to the right of the line from the exterior to the left of theline.

FIG. 234 shows an embodiment of the invention identical to that of FIG.233, except that a reversing device in the form of an electric switch3060 operable for example by polarized energy also is implanted in thepatient for reversing the device 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 3040 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 3020transforms the wireless polarized energy into a polarized current foroperating the electric switch 3060. When the polarity of the current isshifted by the implanted energy-transforming device 3020 the electricswitch 3060 reverses the function performed by the device 10.

FIG. 235 shows an embodiment of the invention identical to that of FIG.233, except that an operation device 3070 implanted in the patient foroperating the device 10 is provided between the implantedenergy-transforming device 3020 and the device 10. This operation devicecan be in the form of a motor 3070, such as an electric servomotor. Themotor 3070 is powered with energy from the implanted energy-transformingdevice 3020, as the remote control of the external energy-transmissiondevice 3040 transmits a wireless signal to the receiver of the implantedenergy-transforming device 3020.

FIG. 236 shows an embodiment of the Invention identical to that of FIG.233, except that it also comprises an operation device is in the form ofan assembly 3080 including a motor/pump unit 3090 and a fluid reservoir3100 is implanted in the patient. In this case the device 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 3090 from the fluid reservoir 3100 through a conduit 3110 to thedevice 10 to operate the device, and hydraulic fluid is pumped by themotor/pump unit 3090 back from the device 10 to the fluid reservoir 3100to return the device to a starting position. The implantedenergy-transforming device 1002 transforms wireless energy into acurrent, for example a polarized current, for powering the motor/pumpunit 1009 via an electric power supply line 3120.

Instead of a hydraulically operated device 10, it is also envisaged thatthe operation device comprises a pneumatic operation device. In thiscase, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 3020 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 238 shows an embodiment of the invention comprising the externalenergy-transmission device 3040 with its wireless remote control, thedevice 10, in this case hydraulically operated, and the implantedenergy-transforming device 3020, and further comprising a hydraulicfluid reservoir 3130, a motor/pump unit 3090 and an reversing device inthe form of a hydraulic valve shifting device 3140, all implanted in thepatient. Of course the hydraulic operation could easily be performed byjust changing the pumping direction and the hydraulic valve maytherefore be omitted. The remote control may be a device separated fromthe external energy-transmission device or included in the same. Themotor of the motor/pump unit 3090 is an electric motor. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 3040, the implanted energy-transformingdevice 3020 powers the motor/pump unit 3090 with energy from the energycarried by the control signal, whereby the motor/pump unit 3090distributes hydraulic fluid between the hydraulic fluid reservoir 3130and the device 10. The remote control of the externalenergy-transmission device 3040 controls the hydraulic valve shiftingdevice 3140 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 3090 fromthe hydraulic fluid reservoir 3130 to the device 10 to operate thedevice, and another opposite direction in which the fluid is pumped bythe motor/pump unit 3090 back from the device 10 to the hydraulic fluidreservoir 3130 to return the device to a starting position.

FIG. 239 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, thedevice 10, the implanted energy-transforming device 3020, an implantedinternal control unit 3150 controlled by the wireless remote control ofthe external energy-transmission device 3040, an implanted accumulator3160 and an implanted capacitor 3170. The internal control unit 1015arranges storage of electric energy received from the implantedenergy-transforming device 3020 in the accumulator 3160, which suppliesenergy to the device 10. In response to a control signal from thewireless remote control of the external energy-transmission device 3040,the internal control unit 3150 either releases electric energy from theaccumulator 3160 and transfers the released energy via power lines 3180and 3190, or directly transfers electric energy from the implantedenergy-transforming device 3020 via a power line 3200, the capacitor3170, which stabilizes the electric current, a power line 3210 and thepower line 3190, for the operation of the device 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the device 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 3170 in the embodimentof FIG. 224 may be omitted. In accordance with another alternative, theaccumulator 3160 in this embodiment may be omitted.

FIG. 240 shows an embodiment of the invention identical to that of FIG.234, except that a battery 3220 for supplying energy for the operationof the device 10 and an electric switch 3230 for switching the operationof the device 10 also are implanted in the patient. The electric switch3230 may be controlled by the remote control and may also be operated bythe energy supplied by the implanted energy-transforming device 3020 toswitch from an off mode, in which the battery 3220 is not in use, to anon mode, in which the battery 3220 supplies energy for the operation ofthe device 10.

FIG. 241 shows an embodiment of the invention identical to that of FIG.240, except that an internal control unit 3150 controllable by thewireless remote control of the external energy-transmission device 3040also is implanted in the patient. In this case, the electric switch 3230is operated by the energy supplied by the implanted energy-transformingdevice 3020 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 3150 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 3150 torelease electric energy from the battery 3220 for the operation of thedevice 10.

FIG. 242 shows an embodiment of the invention identical to that of FIG.241, except that an accumulator 3160 is substituted for the battery 3220and the implanted components are interconnected differently. In thiscase, the accumulator 3160 stores energy from the implantedenergy-transforming device 3020. In response to a control signal fromthe wireless remote control of the external energy-transmission device3040, the internal control unit 3150 controls the electric switch 3230to switch from an off mode, in which the accumulator 3160 is not in use,to an on mode, in which the accumulator 3160 supplies energy for theoperation of the device 10. The accumulator may be combined with orreplaced by a capacitor.

FIG. 243 shows an embodiment of the invention identical to that of FIG.242, except that a battery 3220 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 3040, the internal control unit 3150 controlsthe accumulator 3160 to deliver energy for operating the electric switch3230 to switch from an off mode, in which the battery 3220 is not inuse, to an on mode, in which the battery 3220 supplies electric energyfor the operation of the device 10.

Alternatively, the electric switch 3230 may be operated by energysupplied by the accumulator 3160 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery3220 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery3220 to supply electric energy for the operation of the device 10.

It should be understood that the switch 3230 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 244 shows an embodiment of the invention identical to that of FIG.240, except that a motor 3070, a mechanical reversing device in the formof a gear box 3240, and an internal control unit 3150 for controllingthe gear box 3240 also are implanted in the patient. The internalcontrol unit 3150 controls the gear box 3240 to reverse the functionperformed by the device 10 (mechanically operated). Even simpler is toswitch the direction of the motor electronically. The gear boxinterpreted in its broadest embodiment may stand for a servo arrangementsaving force for the operation device in favor of longer stroke to act.

FIG. 245 shows an embodiment of the invention identical to that of FIG.241 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 3150 is powered by thebattery 3220 when the accumulator 3160, suitably a capacitor, activatesthe electric switch 3230 to switch to an on mode. When the electricswitch 3230 is in its on mode the internal control unit 3150 ispermitted to control the battery 3220 to supply, or not supply, energyfor the operation of the device 10.

FIG. 246 schematically shows conceivable combinations of implantedcomponents of the device for achieving various communication options.Basically, there are the device 10, the internal control unit 3150,motor or pump unit 3090, and the external energy-transmission device3040 including the external wireless remote control. As alreadydescribed above the wireless remote control transmits a control signalwhich is received by the internal control unit 3150, which in turncontrols the various implanted components of the device.

A feedback device, preferably comprising a sensor or measuring device3250, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 3250 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 3150, or alternatively the external wirelessremote control of the external energy-transmission device 3040, maycontrol the device 10 in response to signals from the sensor 3250. Atransceiver may be combined with the sensor 3250 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 3150 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit3150 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the device 10 from inside the patient'sbody to the outside thereof.

Where the motor/pump unit 3090 and battery 3220 for powering themotor/pump unit 3090 are implanted, information related to the chargingof the battery 3220 may be fed back. To be more precise, when charging abattery or accumulator with energy feedback information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 247 shows an alternative embodiment wherein the device 10 isregulated from outside the patient's body. The system 3000 comprises abattery 3220 connected to the device 10 via a subcutaneous electricswitch 3260. Thus, the regulation of the device 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the device 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 248 shows an alternative embodiment, wherein the system 3000comprises a hydraulic fluid reservoir 3130 hydraulically connected tothe device. Non-invasive regulation is performed by manually pressingthe hydraulic reservoir connected to the device.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to the deviceor the patient to the external data communicator and/or the externaldata communicator feeds data to the internal data communicator.

FIG. 249 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the device or system, or related to a physicalparameter of the patient, in order to supply an accurate amount ofenergy to an implanted internal energy receiver 3020 connected toimplanted energy consuming components of the device 10. Such an energyreceiver 3020 may include an energy source and/or an energy-transformingdevice. Briefly described, wireless energy is transmitted from anexternal energy source 3040 a located outside the patient and isreceived by the internal energy receiver 3020 located inside thepatient. The internal energy receiver is adapted to directly orindirectly supply received energy to the energy consuming components ofthe device 10 via a switch 3260. An energy balance is determined betweenthe energy received by the internal energy receiver 3020 and the energyused for the device 10, and the transmission of wireless energy is thencontrolled based on the determined energy balance. The energy balancethus provides an accurate indication of the correct amount of energyneeded, which is sufficient to operate the device 10 properly, butwithout causing undue temperature rise.

In FIG. 249 the patient's skin is indicated by a vertical line 3050.Here, the energy receiver comprises an energy-transforming device 1002located inside the patient, preferably just beneath the patient's skin3050. Generally speaking, the implanted energy-transforming device 1002may be placed in the abdomen, thorax, muscle fascia (e.g. in theabdominal wall), subcutaneously, or at any other suitable location. Theimplanted energy-transforming device 3020 is adapted to receive wirelessenergy E transmitted from the external energy-source 3040 a provided inan external energy-transmission device 3040 located outside thepatient's skin 3050 in the vicinity of the implanted energy-transformingdevice 3020.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 3020. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the device, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of the device.The term “energy used” is then understood to include also energy storedby implanted components of the device. A control device includes anexternal control unit 3040 b that controls the external energy source3040 a based on the determined energy balance to regulate the amount oftransferred energy. In order to transfer the correct amount of energy,the energy balance and the required amount of energy is determined bymeans of a determination device including an implanted internal controlunit 3150 connected between the switch 3260 and the device 10. Theinternal control unit 3150 may thus be arranged to receive variousmeasurements obtained by suitable sensors or the like, not shown,measuring certain characteristics of the device 10, somehow reflectingthe required amount of energy needed for proper operation of the device10. Moreover, the current condition of the patient may also be detectedby means of suitable measuring devices or sensors, in order to provideparameters reflecting the patient's condition. Hence, suchcharacteristics and/or parameters may be related to the current state ofthe device 10, such as power consumption, operational mode andtemperature, as well as the patient's condition reflected by parameterssuch as; body temperature, blood pressure, heartbeats and breathing.Other kinds of physical parameters of the patient and functionalparameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 3160 mayoptionally be connected to the implanted energy-transforming device 3020via the control unit 3150 for accumulating received energy for later useby the device 10. Alternatively or additionally, characteristics of suchan accumulator, also reflecting the required amount of energy, may bemeasured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the device 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 3020, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 3150. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 3150 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the device 10, or the patient, or an implanted energy sourceif used, or any combination thereof. The internal control unit 3150 isfurther connected to an internal signal transmitter 3270, arranged totransmit a control signal reflecting the determined required amount ofenergy, to an external signal receiver 3040 c connected to the externalcontrol unit 3040 b. The amount of energy transmitted from the externalenergy source 3040 a may then be regulated in response to the receivedcontrol signal.

Alternatively, the determination device may include the external controlunit 3040 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 3040 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 3040 b, thus integrating the above-describedfunction of the internal control unit 3150 in the external control unit3040 b. In that case, the internal control unit 3150 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 3270 which sends the measurements over to the externalsignal receiver 3040 c and the external control unit 3040 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 3040 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 249employs the feedback of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the device. The device may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the device.

The internal signal transmitter 3270 and the external signal receiver3040 c may be implemented as separate units using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 3270 and the externalsignal receiver 3040 c may be integrated in the implantedenergy-transforming device 3020 and the external energy source 3040 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 249, the switch 3260is either separate and controlled by the internal control unit 3150, orintegrated in the internal control unit 3150. It should be understoodthat the switch 3260 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 249 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 3150 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 3150, and the control signalis transmitted from the internal signal transmitter 3270 to the externalsignal receiver 3040 c. Alternatively, the energy balance can bedetermined by the external control unit 3040 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 3040 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 3040 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 250, although wireless transfer of energy foroperating the device has been described above to enable non-invasiveoperation, it will be appreciated that the device can be operated withwire bound energy as well. Such an example is shown in FIG. 250, whereinan external switch 3260 is interconnected between the external energysource 3040 a and an operation device, such as an electric motor 3070operating the device 10. An external control unit 3040 b controls theoperation of the external switch 3260 to effect proper operation of thedevice 10.

FIG. 251 illustrates different embodiments for how received energy canbe supplied to and used by the device 10. Similar to the example of FIG.249, an internal energy receiver 3020 receives wireless energy E from anexternal energy source 3040 a which is controlled by a transmissioncontrol unit 3040 b. The internal energy receiver 3020 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the device 10. Theinternal energy receiver 3020 may further comprise a constant currentcircuit, indicated as a dashed box “constant C” in the figure, forsupplying energy at constant current to the device 10.

The device 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The device 10 may furthercomprise an energy storage device 10 b for storing energy supplied fromthe internal energy receiver 3020. Thus, the supplied energy may bedirectly consumed by the energy consuming part 10 a, or stored by theenergy storage device 10 b, or the supplied energy may be partlyconsumed and partly stored. The device 10 may further comprise an energystabilizing unit 10 c for stabilizing the energy supplied from theinternal energy receiver 3020. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 3020 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit3280 located outside the device 10, before being consumed and/or storedby the device 10. Alternatively, the energy stabilizing unit 3280 may beintegrated in the internal energy receiver 3020. In either case, theenergy stabilizing unit 3280 may comprise a constant voltage circuitand/or a constant current circuit.

It should be noted that FIG. 249 and FIG. 251 illustrate some possiblebut non-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 252 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of thedevice, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 252 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the device of thepresent invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 235; the transmitting partsof the system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 252and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 252 the symbols Y1, Y2, Y3 and so on symbolize test pointswithin the circuit. The components in the diagram and their respectivevalues are values that work in this particular implementation which ofcourse is only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 3060 of FIG. 235 could be incorporated in any of theembodiments of FIGS. 238-244, the hydraulic valve shifting device 3140of FIG. 238 could be incorporated in the embodiment of FIG. 237, and thegear box 3240 could be incorporated in the embodiment of FIG. 236.Please observe that the switch simply could mean any electronic circuitor component.

The embodiments described in connection with FIGS. 249, 251 and 252identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable device. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of a device asdescribed above. The wireless energy E is transmitted from an externalenergy source located outside the patient and is received by an internalenergy receiver located inside the patient, the internal energy receiverbeing connected to the implanted energy consuming components of thedevice for directly or indirectly supplying received energy thereto. Anenergy balance is determined between the energy received by the internalenergy receiver and the energy used for the device. The transmission ofwireless energy E from the external energy source is then controlledbased on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising a device as described above is thus also providedfor controlling transmission of wireless energy supplied to implantedenergy consuming components of the device. In its broadest sense, thesystem comprises a control device for controlling the transmission ofwireless energy from an energy-transmission device, and an implantableinternal energy receiver for receiving the transmitted wireless energy,the internal energy receiver being connected to implantable energyconsuming components of the device for directly or indirectly supplyingreceived energy thereto. The system further comprises a determinationdevice adapted to determine an energy balance between the energyreceived by the internal energy receiver and the energy used for theimplantable energy consuming components of the device, wherein thecontrol device controls the transmission of wireless energy from theexternal energy-transmission device, based on the energy balancedetermined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the device, and the control device controls the transmission of        wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the device is consumed to operate the        device, and/or stored in at least one energy storage device of        the device.    -   Where electrical and/or physical parameters of the device and/or        physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 253-256 show in more detail block diagrams of four different waysof hydraulically or pneumatically powering an implanted device accordingto the invention.

FIG. 253 shows a system as described above with. The system comprises animplanted device 10 and further a separate regulation reservoir 10130, aone way pump 10090 and an alternate valve 10140.

FIG. 254 shows the device 10 and a fluid reservoir 10130. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the device may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 255 shows the device 10, a two way pump 10090 and the regulationreservoir 10130.

FIG. 256 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 10130 and a servo reservoir 10500. Theservo reservoir 10500 mechanically controls an implanted device 10 via amechanical interconnection 10540. The device has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 10520 in fluid connection with the device 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 10500.

The servo reservoir 10500 can also be part of the device itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 257a-c . InFIG. 257a , a flexible subcutaneous regulation reservoir 10130 is shownconnected to a bulge shaped servo reservoir 10500 by means of a conduit10110. This bellow shaped servo reservoir 10500 is comprised in aflexible device 10. In the state shown in FIG. 257a , the servoreservoir 10500 contains a minimum of fluid and most fluid is found inthe regulation reservoir 10130. Due to the mechanical interconnectionbetween the servo reservoir 10500 and the device 10, the outer shape ofthe device 10 is contracted, i.e., it occupies less than its maximumvolume. This maximum volume is shown with dashed lines in the figure.

FIG. 257b shows a state wherein a user, such as the patient in with thedevice is implanted, presses the regulation reservoir 10130 so thatfluid contained therein is brought to flow through the conduit 10110 andinto the servo reservoir 10500, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the device 10 sothat it occupies its maximum volume, thereby stretching the stomach wall(not shown), which it contacts.

The regulation reservoir 10130 is preferably provided with means 10130 afor keeping its shape after compression. This means, which isschematically shown in FIG. 257c , will thus keep the device 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 258 and 259 a-c. The block diagramshown in FIG. 258 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir10130 and a servo reservoir 10500. The servo reservoir 10500mechanically controls a larger adjustable reservoir 10520 via amechanical interconnection 10540. An implanted device 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 10520 by supply of hydraulic fluid from the largeradjustable reservoir 10520 in fluid connection with the device 10.

An example of this embodiment will now be described with reference toFIG. 259a-c . Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 10130 is in fluid connection with a bellow shaped servoreservoir 10500 by means of a conduit 10110. In the first closed system10130, 10110, 10500 shown in FIG. 259a , the servo reservoir 10500contains a minimum of fluid and most fluid is found in the regulationreservoir 10130.

The servo reservoir 10500 is mechanically connected to a largeradjustable reservoir 10520, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 10500. The largeradjustable reservoir 1052 is in fluid connection with the device 10.This means that when a user pushes the regulation reservoir 10130,thereby displacing fluid from the regulation reservoir 10130 to theservo reservoir 10500, the expansion of the servo reservoir 10500 willdisplace a larger volume of fluid from the larger adjustable reservoir10520 to the device 10. In other words, in this reversed servo, a smallvolume in the regulation reservoir is compressed with a higher force andthis creates a movement of a larger total area with less force per areaunit.

Like in the previous embodiment described above with reference to FIGS.257a-c , the regulation reservoir 10130 is preferably provided withmeans 10130 a for keeping its shape after compression. This means, whichis schematically shown in the figure, will thus keep the device 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

Please note that any embodiment, of a device or system, or part ofembodiment as well as any method or part of method could be combined inany way. All examples herein should be seen as part of the generaldescription and therefore possible to combine in any way in generalterms.

What is claimed is:
 1. A laparoscopic method for implanting a flowcontrol apparatus for controlling a flow of fluid and/or other matter ina lumen formed by a tissue wall of a patient's organ, comprising:inserting a tube into the patient's body, filling, through said tube,gas into a location within the patient's body, cutting a hole in theskin of the body, inserting, through said hole, at least onelaparoscopic trocar towards the location, advancing a dissecting tooland a camera through the at least one trocar towards said location,dissecting, by means of the dissecting tool, an area of a tubular partof said lumen, placing an implantable constriction device at the tubularpart of the lumen, wherein the constriction device is adapted tosimultaneously constrict three or more wall portions of the lumen so asto influence the flow in the lumen, wherein the constriction device isadapted to constrict said wall portions to a constricted state in whicha blood circulation in the constricted wall portions is substantiallyunrestricted and the flow in the lumen is at least restricted, placingan implantable stimulation device at the tubular part of the lumen,wherein the stimulation device is adapted to independently andindividually stimulate a selected wall portion of the at least threewall portions, wherein the constriction device and the stimulationdevice are configured to be controlled by a control device, such that:the stimulation device, when the constriction device constricts the atleast three wall portions, stimulates the selected wall portion to causecontraction of the selected wall portion to further influence the flowin the lumen, the stimulation device, when the constriction device isholding the at least three wall portions in a constricted state,intermittently and individually stimulates different wall portions ofthe at least three wall portions such that at least two of the at leastthree wall portions are stimulated at different points of time, thestimulation device intermittently stimulates the different wall portionsduring successive time periods, the constriction device adjusts theconstriction of the at least three wall portions, such that the flow inthe lumen is restricted but not stopped, the stimulation devicestimulates the constricted wall portions individually to causecontraction thereof, such that the flow in the lumen is furtherrestricted but not stopped, or the stimulation device is operated in afirst mode to stimulate the constricted wall portions individually tostop the flow in the lumen and in a second mode to cease the stimulationof the wall portion to allow flow in the lumen.
 2. The method accordingto claim 1, further comprising: implanting the control device in thepatient's body.
 3. The method according to claim 2, further comprising:subcutaneously implanting a manually operable switch for operating thecontrol device to switch on and off the constriction device and/orstimulation device.
 4. The method according to claim 3, wherein theswitch is adapted to be manually operated from outside the patient'sbody.
 5. The method according to claim 1, further comprising: implantinga sensor configured to sense a physical parameter of the patient, theparameter relating to a pressure in the lumen.
 6. The method accordingto claim 1, wherein the stimulation device is placed to stimulate musclefibers of the lumen so as to contract said muscle fibers.
 7. The methodaccording to claim 1, wherein the stimulation device comprises aplurality of electrical elements forming an elongate pattern, andwherein the stimulation device is placed on the lumen such that theelongate pattern extends along the direction of the flow in the lumen.8. The method according to claim 7, wherein the stimulation device isplaced such that the electrical elements abut the respective wallportions of the lumen.
 9. The method according to claim 1, furthercomprising implanting an internal signal receiver and/or transmitter forreceiving signals transmitted from an external signal transmitter ortransmitting signals to an external signal receiver.
 10. The methodaccording to claim 1, further comprising implanting an internal energysource for powering energy consuming components of the constrictiondevice and/or stimulation device.
 11. The method according to claim 1,further comprising implanting a feedback device for sending feedbackinformation from inside the patient's body to the outside thereof. 12.The method according to claim 1, further comprising implanting anoperation device for operating the constriction device.
 13. The methodaccording to claim 12, wherein the operation device is a hydraulicoperation device.
 14. The method according to claim 1, furthercomprising implanting an energy-transforming device for transformingwireless energy, transmitted by an energy-transmission device, from afirst form into a second form of energy.